Consulting Wallah › Device Explorer › Other devices › Biopsy punch, reusable
Device Explorer · FDA GUDID · GMDN 35286

Biopsy punch, reusable

A manual surgical instrument designed to obtain a tissue or bone sample typically for histopathological analysis. The instrument may be ring-handled, pistol grip, or shaft-like in design. Ring-handled or pistol grip designs feature extended shafts which termin

US‑registered devices76in commercial distribution
Companies7labelers on GUDID
Single‑use1%of device records
Sterile9%labelled sterile
Prescription83%Rx‑only share
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Share of device records

Elmed Incorporated4357%
Sklar Corporation1317%
Karl Storz Gmbh & Co. Kg79%
Park Dental Research Corp68%
Avalign Technologies, Inc.34%
Argon Medical Devices, Inc.34%
Seaspine Orthopedics Corporation11%

Top labelers

CompanyDevicesShare
Elmed Incorporated4357%
Sklar Corporation1317%
Karl Storz Gmbh & Co. Kg79%
Park Dental Research Corp68%
Avalign Technologies, Inc.34%
Argon Medical Devices, Inc.34%
Seaspine Orthopedics Corporation11%

Company = labeler of record on GUDID. 7 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

SilCutn.a.ELMEDPark Dental Research Corp.PillingPro-Mag Ultra 2.2 Automatic Biopsy InstrumentPro-Mag™ Ultra ST Automatic Biopsy InstrumentPro-Mag™ Ultra Automatic Biopsy InstrumentAspirex PlusSklar®

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

FDA product codes

CodeNameDevices
GCJLaparoscope, General & Plastic Surgery43
GCJLaparoscope, general & plastic surgery13
NDPAccessories, Implant, Dental, Endosseous6
HRXARTHROSCOPE3
KNWInstrument, Biopsy3
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT2

GMDN & GCC registration

  • GMDN code 35286 · non‑implantable
  • Single‑use 1% · sterile 9% · Rx‑only 83% · 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

Length (Centimeter) · 2Width (Millimeter) · 2

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

How many biopsy punch, reusable products are registered in the US?

76 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Biopsy punch, reusable", from 7 companies. The largest labeler is Elmed Incorporated with 57% of records.

Which FDA product codes apply?

GCJ (Laparoscope, General & Plastic Surgery), GCJ (Laparoscope, general & plastic surgery), NDP (Accessories, Implant, Dental, Endosseous), HRX (ARTHROSCOPE)

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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