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Device Explorer · FDA GUDID · GMDN 35287

Bone punch, reusable

A hand-held manual surgical instrument with a cutting/biting action used to cut small cross-sectional pieces of bone typically for biopsy or fixation procedures during a surgical intervention. It is typically designed with a long, thin, two-part sliding shaft

US‑registered devices551in commercial distribution
Companies11labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription83%Rx‑only share
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Share of device records

Vitalitec International Medizintechnik Gmbh21238%
Smith & Nephew, Inc.11220%
Sopro-Comeg Gmbh5911%
National Advanced Endoscopy Devices, Inc.5710%
Karl Storz Gmbh & Co. Kg509%
Biomet Orthopedics, Llc489%
Tontarra Medizintechnik Gmbh61%
Globus Medical, Inc.41%

Top labelers

CompanyDevicesShare
Vitalitec International Medizintechnik Gmbh21238%
Smith & Nephew, Inc.11220%
Sopro-Comeg Gmbh5911%
National Advanced Endoscopy Devices, Inc.5710%
Karl Storz Gmbh & Co. Kg509%
Biomet Orthopedics, Llc489%
Tontarra Medizintechnik Gmbh61%
Globus Medical, Inc.41%
Biomet Uk Ltd10%
Biomet Microfixation, Inc10%
Kalitec Direct Llc10%

Company = labeler of record on GUDID. 11 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

TC-PLUS Revision / RT-PLUSAGC TIBIAL PUNCHQuick ReleaseQUICK RELEASEVitalitecStone basketPunchTontarra Medizintechnik GmbHn.a.SilCutRHINOFORCEARTHROFORCE / Take-ApartSinuFITGENESIS IIN/AVanguard

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

FDA product codes

CodeNameDevices
HAERONGEUR, MANUAL258
HRXARTHROSCOPE61
HRYPROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, 50
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT34
HWPPUNCH, FEMORAL NECK33
JWHPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEM29

GMDN & GCC registration

  • GMDN code 35287 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 83% · OTC 1%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Width (Millimeter) · 4

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

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

551 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Bone punch, reusable", from 11 companies. The largest labeler is Vitalitec International Medizintechnik Gmbh with 38% of records.

Which FDA product codes apply?

HAE (RONGEUR, MANUAL), HRX (ARTHROSCOPE), HRY (PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, ), LXH (ORTHOPEDIC MANUAL SURGICAL INSTRUMENT)

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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