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Device Explorer · FDA GUDID · GMDN 42997

Surgical instrument/implant rack

A device designed as a small case, typically with a hinged lid that can be closed to protect the contents (i.e., surgical instruments and/or implantable devices such as plates or screws), and an integral rest(s) with grooves or notches in the upper edge so tha

US‑registered devices3,806in commercial distribution
Companies76labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription89%Rx‑only share
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Share of device records

Synthes Gmbh1,46739%
Kls-Martin L.P.57915%
Aesculap Ag3249%
Aap Implantate Ag1835%
Nvision Biomedical Technologies, Inc.1053%
Medos International Sàrl1043%
Biomet Microfixation, Inc762%
Stryker Gmbh752%

Top labelers

CompanyDevicesShare
Synthes Gmbh1,46739%
Kls-Martin L.P.57915%
Aesculap Ag3249%
Aap Implantate Ag1835%
Nvision Biomedical Technologies, Inc.1053%
Medos International Sàrl1043%
Biomet Microfixation, Inc762%
Stryker Gmbh752%
Kalitec Direct Llc682%
Orthopediatrics Canada Ulc662%
B-One Ortho, Corp.571%
Accurate Surgical & Scientific Instruments Corporation561%

Company = labeler of record on GUDID. 76 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Patient-Fitted TMJ Reconstructive Prosthesis SysASNISPANGEAANCHORAGEVARIAXAXSOSBIXCUTOMEGANAMATTA - PELVICGIRO GROWTH MODULATION SYSTEMGAP ENDO-EXO MEDULLARY SYSTEMFASSIER-DUVAL TELESCOPIC IM SYSTEMDr.Paleys Osteotomy SystemHINGE PEDIATRIC PLATING SYSTEMSIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM

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

FDA product codes

CodeNameDevices
FSMTRAY, SURGICAL, INSTRUMENT2,996
FSMTray, Surgical, Instrument255
LRPTray, Surgical188
LRPTRAY, SURGICAL110
LXHOrthopedic Manual Surgical Instrument105
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT103

GMDN & GCC registration

  • GMDN code 42997 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 89% · OTC 5%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Length (Millimeter) · 15Width (Millimeter) · 10Depth (Millimeter) · 9Length (Inch) · 5Outer Diameter (Millimeter) · 4Angle (degree) · 4

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

How many surgical instrument/implant rack products are registered in the US?

3,806 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Surgical instrument/implant rack", from 76 companies. The largest labeler is Synthes Gmbh with 39% of records.

Which FDA product codes apply?

FSM (TRAY, SURGICAL, INSTRUMENT), FSM (Tray, Surgical, Instrument), LRP (Tray, Surgical), LRP (TRAY, 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.

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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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