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Device Explorer · FDA GUDID · GMDN 32312

Surgical mallet

A hand-held manual surgical instrument designed to strike a surface or another device (e.g., a surgical chisel, gouge, driver) to drive it during a surgical intervention. It is available in a variety of designs and materials; the shaft is typically made of met

US‑registered devices1,927in commercial distribution
Companies229labelers on GUDID
Single‑use3%of device records
Sterile1%labelled sterile
Prescription64%Rx‑only share
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Share of device records

Med Saver, Inc.1246%
Avalign Technologies, Inc.1055%
Surgical Direct, Inc.844%
Sklar Corporation834%
Gsource Llc673%
Integra Lifesciences Production Corporation523%
Anmuth Medical International, Llc523%
Boss Instruments, Ltd., Inc.432%

Top labelers

CompanyDevicesShare
Med Saver, Inc.1246%
Avalign Technologies, Inc.1055%
Surgical Direct, Inc.844%
Sklar Corporation834%
Gsource Llc673%
Integra Lifesciences Production Corporation523%
Anmuth Medical International, Llc523%
Boss Instruments, Ltd., Inc.432%
Novo Surgical, Inc.432%
Teleflex Incorporated432%
Ambler Surgical Corp.402%
Surtex Instruments Ltd.362%

Company = labeler of record on GUDID. 229 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Tritanium TLNATritanium CINSTRUMENTREUNIONAero-LLRELIANCE ALRELIANCEES2 SPINAL SYSTEMRELIANCE LITeAero-COMEGAARIATC-PLUS / RT-PLUSPROMOSSL-PLUS

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

FDA product codes

CodeNameDevices
GFJMALLET, SURGICAL, GENERAL & PLASTIC SURGERY449
HXLMALLET417
GFJMallet, Surgical, General & Plastic Surgery293
FZYHAMMER, SURGICAL141
LXHOrthopedic Manual Surgical Instrument128
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT98

GMDN & GCC registration

  • GMDN code 32312 · non‑implantable
  • Single‑use 3% · sterile 1% · Rx‑only 64% · 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 (Inch) · 141Length (Centimeter) · 42Width (Millimeter) · 29Outer Diameter (Inch) · 13Weight (Pound) · 11Outer Diameter (Millimeter) · 10

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

How many surgical mallet products are registered in the US?

1,927 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Surgical mallet", from 229 companies. The largest labeler is Med Saver, Inc. with 6% of records.

Which FDA product codes apply?

GFJ (MALLET, SURGICAL, GENERAL & PLASTIC SURGERY), HXL (MALLET), GFJ (Mallet, Surgical, General & Plastic Surgery), FZY (HAMMER, SURGICAL)

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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