Consulting Wallah › Device Explorer › Procedure kits & trays › Bone marrow biopsy procedure kit
Device Explorer · FDA GUDID · GMDN 16833

Bone marrow biopsy procedure kit

A packaged collection of sterile equipment that includes a disposable biopsy needle and other supplies used to perform a histologic specimen aspiration during a bone marrow biopsy. This is a single-use device.

US‑registered devices395in commercial distribution
Companies23labelers on GUDID
Single‑use99%of device records
Sterile97%labelled sterile
Prescription87%Rx‑only share
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Share of device records

Biopsybell Srl11429%
Izi Medical Products, Llc4712%
Sterylab Srl4010%
Manus Medical, Llc359%
Arthrex, Inc.236%
Carefusion 2200, Inc236%
Zhejiang Curaway Medical Technology Co., Ltd.205%
Robert Busse & Co., Inc.164%

Top labelers

CompanyDevicesShare
Biopsybell Srl11429%
Izi Medical Products, Llc4712%
Sterylab Srl4010%
Manus Medical, Llc359%
Arthrex, Inc.236%
Carefusion 2200, Inc236%
Zhejiang Curaway Medical Technology Co., Ltd.205%
Robert Busse & Co., Inc.164%
Ranfac Corp.154%
Surgentec, Llc113%
Cardinal Health 200, Llc113%
Centurion Medical Products Corporation92%

Company = labeler of record on GUDID. 23 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

CurawayArthrex®TRAY, CBMT-DH-11B, F/GMaxx CellRanfac Marrow Cellution Aspiration Needle 13GA XSite Prep Barbed Guide +4Site Prep Barbed Guide +2Site Prep Barbed GuideSite Prep Locator - Row SeriesBusse Hospital DisposablesBLAZER-C CURVED INJECTION SYSTEM-MVDBBN-13-15.0-M1M-JPDBBN-15-10.0 CERV-JPDBBN-13-15.0-M2-JPDBBN-13-15.0-JPDBBN-13-10.0-M2-JP

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

FDA product codes

CodeNameDevices
KNWInstrument, Biopsy241
FCGBiopsy Needle156
KNWINSTRUMENT, BIOPSY33
LROGeneral Surgery Tray26
GAANEEDLE, ASPIRATION AND INJECTION, DISPOSABLE23
PRVGastro-Urology Biopsy Kit17

GMDN & GCC registration

  • GMDN code 16833 · non‑implantable
  • Single‑use 99% · sterile 97% · Rx‑only 87% · 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) · 166Length (Millimeter) · 114Length (Inch) · 37Length (Centimeter) · 6

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

How many bone marrow biopsy procedure kit products are registered in the US?

395 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Bone marrow biopsy procedure kit", from 23 companies. The largest labeler is Biopsybell Srl with 29% of records.

Which FDA product codes apply?

KNW (Instrument, Biopsy), FCG (Biopsy Needle), KNW (INSTRUMENT, BIOPSY), LRO (General Surgery Tray)

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.

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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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