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Device Explorer · FDA GUDID · GMDN 34004

Surgical instrument guard, reusable

A device designed to be applied to a variety of surgical or invasive instruments to protect the instrument and/or its operator and/or the patient from injury, distortion, or damage during an procedure, handling, and/or storage. It is typically made of stainles

US‑registered devices746in commercial distribution
Companies50labelers on GUDID
Single‑use16%of device records
Sterile0%labelled sterile
Prescription68%Rx‑only share
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Share of device records

Smith & Nephew, Inc.17123%
Medline Industries, Inc.8211%
Tornier, Inc.537%
Scanlan International Inc527%
Wright Medical Technology, Inc.415%
Medtronic Navigation, Inc.314%
Cardinal Health, Inc.304%
Innomed, Inc.284%

Top labelers

CompanyDevicesShare
Smith & Nephew, Inc.17123%
Medline Industries, Inc.8211%
Tornier, Inc.537%
Scanlan International Inc527%
Wright Medical Technology, Inc.415%
Medtronic Navigation, Inc.314%
Cardinal Health, Inc.304%
Innomed, Inc.284%
Steris Corporation243%
Conmed Corporation243%
De Soutter Medical Limited203%
Zirc Dental Products, Inc.193%

Company = labeler of record on GUDID. 50 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

INSTRUMENTNAVIGATED MANTISNAFRIOS®De Soutter MedicalSilicone insert forSilicone tubing, slitevonosn.a.ELAN 4AESCULAPEndo-Model Knee System - InstrumentsLINK Instruments - Impactors, extractors and insLINK Instruments - Saw and drill guidesLink Embrace Shoulder System - InstrumentsQUANTUM

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

FDA product codes

CodeNameDevices
HRYPROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, 120
MDMINSTRUMENT, MANUAL, SURGICAL, GENERAL USE100
LXHOrthopedic manual surgical instrument92
FWZOperating Room Accessories Table Tray68
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT50
KCTSterilization wrap containers, trays, cassettes & other acce44

GMDN & GCC registration

  • GMDN code 34004 · non‑implantable
  • Single‑use 16% · sterile 0% · Rx‑only 68% · OTC 18%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Width (Inch) · 43Length (Inch) · 43Length (Millimeter) · 20Width (Millimeter) · 20Height (Millimeter) · 20Outer Diameter (Millimeter) · 8

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

How many surgical instrument guard, reusable products are registered in the US?

746 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Surgical instrument guard, reusable", from 50 companies. The largest labeler is Smith & Nephew, Inc. with 23% of records.

Which FDA product codes apply?

HRY (PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, ), MDM (INSTRUMENT, MANUAL, SURGICAL, GENERAL USE), LXH (Orthopedic manual surgical instrument), FWZ (Operating Room Accessories Table 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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