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Ranfac RAN-11B — 11 gauge × 11 cm fenestrated bone marrow aspiration needle with extra-blunt stylet, single-use, sterile
FDA Cleared · K131157 Single Use · Sterile EO Latex-Free
Bone Marrow Aspiration · Fenestrated · Extra-Blunt

11 Gauge × 11 cm Bone Marrow Aspiration Needle (Fenestrated, Extra-Blunt Stylet)

Single-use 11 gauge × 11 cm bone marrow aspiration needle with a side-port (fenestrated) cannula and an extra-blunt stylet. The blunt-stylet configuration supports needle exchange or re-entry techniques where sharp-tip penetration is undesirable.

CatalogRAN-11B
Part #74107-01M
Gauge11 G
Length11 cm
CannulaSide-port (Fenestrated)
StyletExtra-Blunt

Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.

Overview

The Ranfac RAN-11B is an 11 gauge × 11 centimeter single-use bone marrow aspiration needle with a side-port (fenestrated) cannula and an extra-blunt stylet. The blunt-stylet configuration is intended for procedures that include needle exchange or re-entry into a previously established tract, where a sharp diamond-tip stylet is not appropriate. Each needle ships sterile, ethylene-oxide processed, and individually packaged.

RAN-11B is the extra-blunt-stylet variant of the RAN-11, intended for procedures that include needle exchange or re-entry where a sharp diamond-tip stylet is not appropriate. The cannula itself remains fenestrated, so multi-site aspiration capability is preserved.

Clinical Applications

The Ranfac Bone Marrow Aspiration Needle is intended for use in aspirating bone marrow, as determined by a licensed physician.

The extra-blunt stylet supports needle exchange or re-entry protocols in marrow aspiration, where a sharp stylet would risk additional cortical or soft-tissue trauma. The fenestrated cannula retains the multi-site draw capability of the standard RAN-11.

Hematology & Oncology

Diagnostic marrow evaluation, lymphoma and leukemia workups, treatment monitoring, and metastatic staging.

Orthopedic & Spine

Marrow harvest for orthobiologic preparations used adjunctively to surgical procedures, per physician direction.

Interventional Radiology

Image-guided aspiration where exchange-compatible access or controlled marrow draw is preferred.

Outpatient & Inpatient Settings

Used across hospital hematology and oncology suites, ambulatory surgery centers, and procedure rooms performing routine marrow harvests.

Specifications

RAN-11B Technical Data

Construction, regulatory, and packaging details. Gauge, length, cannula and stylet are listed in the hero above. For complete indications, contraindications, and warnings, download the Instructions for Use.

ConstructionStainless steel cannula and extra-blunt stylet · medical-grade polymer hub
ConnectionFemale luer-lock (accepts standard male luer-lock syringe)
SterilizationEthylene oxide · single-use · latex-free
PackagingIndividually pouched
FDA Clearance510(k) K131157 (22 Oct 2013) · Class II · 21 CFR 876.1075 · Product Code KNW
PrescriptionRx only (21 CFR 801 Subpart D)

Directions for Use (Summary)

The following is a summary only. The complete 10-step Instructions for Use, contraindications, warnings, and disposal requirements are provided in the IFU below.

  1. Inspect packaging. Confirm integrity; if undamaged, open using aseptic technique.
  2. Inspect the device. Check the cannula and stylet cutting edges for damage or imperfections.
  3. Adjust stiffener (if present) to the desired effective length.
  4. Position the needle adjacent to the aspiration site per proper placing technique.
  5. Advance the needle with gentle, firm pressure in alternating clockwise–counterclockwise rotation. Entry into the marrow cavity is generally signaled by decreased resistance.
  6. Remove the stylet by rotating the stylet cap counterclockwise.
  7. Attach a male luer-lock syringe to the needle hub. Avoid glass syringes — they may not seal properly and can fracture.
  8. Apply negative pressure by quickly withdrawing the plunger; disengage and recover the sample.
  9. Dispose of the used device in a sharps biohazard container, per applicable laws and your facility's biohazard policy.

Documents & Downloads

Frequently Asked Questions

What stylet does the RAN-11B use?

An extra-blunt stylet — designed for procedures where needle exchange or re-entry is required and a sharp diamond-tip would risk additional trauma. The cannula itself remains fenestrated.

How is the RAN-11B different from the RAN-11?

Same gauge, length, and fenestrated cannula. The RAN-11 ships with a sharp diamond-tip stylet for initial cortical penetration. RAN-11B ships with an extra-blunt stylet for exchange/re-entry.

Is the RAN-11B FDA cleared?

Yes. The Ranfac Bone Marrow Aspiration Needle family is cleared under 510(k) K131157, regulation 21 CFR 876.1075, product code KNW, device Class II, prescription-use only.

How is the needle sterilized? Is it latex-free?

Sterilized by ethylene oxide (EO) and shipped sterile. The device is not made with natural rubber latex and is intended for single-patient use only.

What other stylet options are available?

The Ranfac BMA portfolio includes sharp diamond-tip configurations (e.g. RAN-1115) and trocar-tip configurations (e.g. RAN-823CM). For custom stylet geometries, contact us about an OEM program.

What syringe size works with this needle?

The female luer-lock hub accepts any standard male luer-lock aspiration syringe. Most operators select 10–20 mL syringes for routine marrow aspiration. Avoid glass syringes — they may not seal properly and can fracture during aspiration.

Related Products

Other configurations in the Ranfac Bone Marrow Aspiration family.

RAN-11 — 11 Gauge × 11 cm Bone Marrow Aspiration Needle (Fenestrated)

RAN-11

Single-use 11 gauge × 11 cm bone marrow aspiration needle with side-port (fenestrated) cannula and diamond-tip stylet

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RAN-1115 — 11 Gauge × 15 cm Bone Marrow Aspiration Needle (Fenestrated)

RAN-1115

Single-use bone marrow aspiration needle with side-port (fenestrated) cannula

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RAN-11N — 11 Gauge × 11 cm Bone Marrow Aspiration Needle (Not Fenestrated)

RAN-11N

Single-use 11 gauge × 11 cm bone marrow aspiration needle with non-fenestrated cannula and diamond-tip stylet

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RAN-823CM — 8 Gauge × 25 cm Bone Marrow Aspiration Needle (Non-Fenestrated, Trocar Stylet)

RAN-823CM

Single-use 8 gauge × 25 cm long-length bone marrow aspiration needle with non-fenestrated cannula and trocar-tip stylet

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Order or Request a Sample of the RAN-11B

Have a clinical question, need samples for evaluation, or ready to purchase? Our product team typically responds within one business day.

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Building a different device on the same platform? Ranfac runs custom OEM, CDMO, and CMO programs from concept through commercial. Talk to us about a custom configuration →