Device Explorer · FDA GUDID · GMDN 12143

Instrument tray, reusable

A container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization p

US‑registered devices31,080in commercial distribution
Companies417labelers on GUDID
Single‑use3%of device records
Sterile0%labelled sterile
Prescription60%Rx‑only share
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Share of device records

Summit Medical, Inc.6,49921%
Medtronic Sofamor Danek, Inc.2,1017%
Smith & Nephew, Inc.1,4455%
Seaspine Orthopedics Corporation1,1604%
Biomet Orthopedics, Llc1,0003%
Highridge Medical, Llc9643%
Stryker Gmbh7462%
Cg Medtech Co.,Ltd.5512%

Top labelers

CompanyDevicesShare
Summit Medical, Inc.6,49921%
Medtronic Sofamor Danek, Inc.2,1017%
Smith & Nephew, Inc.1,4455%
Seaspine Orthopedics Corporation1,1604%
Biomet Orthopedics, Llc1,0003%
Highridge Medical, Llc9643%
Stryker Gmbh7462%
Cg Medtech Co.,Ltd.5512%
Depuy (Ireland)5032%
Orthopediatrics Corp.4752%
Alphatec Spine, Inc.4371%
Nordent Manufacturing Inc4301%

Company = labeler of record on GUDID. 417 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

PANGEAInstrumentNAHOFFMANN LRFT2, PANGEAT2INSTRUMENTRPSMakoMAKO Knee Tray Bottom InsertDouble Tier Tray Outer ShellLower Tray, Mako Shoulder TrayVARIAXREUNIONMMTPRO

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, INSTRUMENT12,027
KCTSterilization Wrap Containers, Trays, Cassettes & Other Acce7,449
FSMTray, Surgical, Instrument4,374
OJHOrthopedic tray1,160
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,066
LRPTRAY, SURGICAL840

GMDN & GCC registration

  • GMDN code 12143 · non‑implantable
  • Single‑use 3% · sterile 0% · Rx‑only 60% · OTC 16%
  • 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) · 570Width (Inch) · 476Height (Inch) · 380Length (Millimeter) · 170Angle (degree) · 157Width (Millimeter) · 118

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

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

31,080 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Instrument tray, reusable", from 417 companies. The largest labeler is Summit Medical, Inc. with 21% of records.

Which FDA product codes apply?

FSM (TRAY, SURGICAL, INSTRUMENT), KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Acce), FSM (Tray, Surgical, Instrument), OJH (Orthopedic 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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