Consulting Wallah › Device Explorer › Procedure kits & trays › Soft-tissue biopsy procedure kit, medicated
Device Explorer · FDA GUDID · GMDN 61922

Soft-tissue biopsy procedure kit, medicated

A collection of sterile devices, which includes a pharmaceutical(s), designed to perform a non-specific soft tissue biopsy (e.g., skin biopsy, breast biopsy); it is not dedicated to biopsy of a specific internal organ. It includes the biopsy needle used for th

US‑registered devices133in commercial distribution
Companies10labelers on GUDID
Single‑use96%of device records
Sterile87%labelled sterile
Prescription81%Rx‑only share
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Share of device records

Medline Industries, Inc.3526%
Centurion Medical Products Corporation3325%
Apollo Medical Products Corp.2116%
Manus Medical, Llc1310%
Medical Action Industries Inc.1310%
Avid Medical, Inc.97%
Argon Medical Devices, Inc.43%
Carefusion 2200, Inc32%

Top labelers

CompanyDevicesShare
Medline Industries, Inc.3526%
Centurion Medical Products Corporation3325%
Apollo Medical Products Corp.2116%
Manus Medical, Llc1310%
Medical Action Industries Inc.1310%
Avid Medical, Inc.97%
Argon Medical Devices, Inc.43%
Carefusion 2200, Inc32%
Carestream Health, Inc.11%
Owens & Minor Distribution, Inc.11%

Company = labeler of record on GUDID. 10 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

General Biopsy TrayMulti-Purpose Biopsy KitManus Medical, LLCCustom Healthcare Systems, Inc.CUSTOM HEALTHCARE SYSTEMS, INCCustom Healthcare Systems Inc.Sterling Medical ProductsCenturionNeedle Core Breast Biopsy Procedure TrayMEDLINEMedichoiceN/AMedical Action IndustriesMEDICAL ACTION INDUSTRIESMAIAVID TruCustom

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

FDA product codes

CodeNameDevices
PXPBreast biopsy / localization tray53
LROGeneral surgery tray48
OJTAspiration Tray20
OFGCT biopsy tray11
LROGeneral Surgery Tray9
OGJNerve Block Tray3

GMDN & GCC registration

  • GMDN code 61922 · non‑implantable
  • Single‑use 96% · sterile 87% · Rx‑only 81% · 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

No structured size data on the register.

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

How many soft-tissue biopsy procedure kit, medicated products are registered in the US?

133 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Soft-tissue biopsy procedure kit, medicated", from 10 companies. The largest labeler is Medline Industries, Inc. with 26% of records.

Which FDA product codes apply?

PXP (Breast biopsy / localization tray), LRO (General surgery tray), OJT (Aspiration Tray), OFG (CT biopsy 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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