Consulting Wallah › Device Explorer › Syringes, needles & infusion › Bone marrow explant needle
Device Explorer · FDA GUDID · GMDN 47612

Bone marrow explant needle

A sterile, sharp bevel-edged, hollow tubular metal instrument designed to percutaneously explant bone marrow (explant is the collection and transfer of living bone marrow from its natural site to a new site, or to a culture medium). The device is typically ava

US‑registered devices74in commercial distribution
Companies5labelers on GUDID
Single‑use100%of device records
Sterile99%labelled sterile
Prescription85%Rx‑only share
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Share of device records

Biopsybell Srl6993%
H.S. Hospital Service Spa23%
Paragon 28, Inc.11%
Alliance Partners Llc11%
M.D.L. S.R.L.11%

Top labelers

CompanyDevicesShare
Biopsybell Srl6993%
H.S. Hospital Service Spa23%
Paragon 28, Inc.11%
Alliance Partners Llc11%
M.D.L. S.R.L.11%

Company = labeler of record on GUDID. 5 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Baby Gorilla/Gorilla Plating SystemSwannShidiCell-HarvestORBIOPSYBELL SRLBIOPSYBELLHARVEST NEEDLE

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
KNWInstrument, Biopsy69
FCGBiopsy Needle61
GAANEEDLE, ASPIRATION AND INJECTION, DISPOSABLE1
KNWINSTRUMENT, BIOPSY1
DWONeedle, Biopsy, Cardiovascular1

GMDN & GCC registration

  • GMDN code 47612 · non‑implantable
  • Single‑use 100% · sterile 99% · Rx‑only 85% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Needle Gauge (Gauge) · 72Length (Millimeter) · 70Length (Centimeter) · 1

Use these as the dimensions to specify in a tender line.

How many bone marrow explant needle products are registered in the US?

74 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Bone marrow explant needle", from 5 companies. The largest labeler is Biopsybell Srl with 93% of records.

Which FDA product codes apply?

KNW (Instrument, Biopsy), FCG (Biopsy Needle), GAA (NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE), KNW (INSTRUMENT, BIOPSY)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

How do I get quotes?

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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