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Device Explorer · FDA GUDID · GMDN 44058

General surgical procedure kit, non-medicated, reusable

A typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures acro

US‑registered devices28,150in commercial distribution
Companies34labelers on GUDID
Single‑use98%of device records
Sterile74%labelled sterile
Prescription99%Rx‑only share
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Share of device records

Medline Industries, Inc.27,38097%
Elmed Incorporated2721%
Novo Health Services, Llc2511%
Cardinal Health, Inc.1070%
Sri Healthcare, Llc270%
Sontec Instruments, Inc.200%
Elevate Textiles, Inc.180%
Avalign Technologies, Inc.170%

Top labelers

CompanyDevicesShare
Medline Industries, Inc.27,38097%
Elmed Incorporated2721%
Novo Health Services, Llc2511%
Cardinal Health, Inc.1070%
Sri Healthcare, Llc270%
Sontec Instruments, Inc.200%
Elevate Textiles, Inc.180%
Avalign Technologies, Inc.170%
Covidien Lp70%
Hermann Medizintechnik Gmbh50%
S.B.M40%
Life Instrument Corporation40%

Company = labeler of record on GUDID. 34 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

SRI SurgicalHermann Medizintechnik GmbHSBMOTIS-FOTIS-C-PLUSOTISQUANTUMClosureFast Tumescent Infiltration KitClosureFast Micro PunctureSpetzler Micro Dissection Instrument SetSI-RESTORESRI HealthcareTensor Surgical VersaTip Suture ShuttleTensor SurgicalMicroAire®ELMED

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

FDA product codes

CodeNameDevices
LROGeneral surgery tray9,860
FDElaparoscopy kit4,111
OEZCardiovascular procedure kit2,584
OESCardiac catheterization kit1,242
OKVObstetrical kit1,234
OIIArthrogram tray1,201

GMDN & GCC registration

  • GMDN code 44058 · non‑implantable
  • Single‑use 98% · sterile 74% · Rx‑only 99% · 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 (Inch) · 551Height (Inch) · 551Weight (Pound) · 551Length (Centimeter) · 6Catheter Gauge (French) · 6Length (Millimeter) · 2

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

How many general surgical procedure kit, non-medicated, reusable products are registered in the US?

28,150 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "General surgical procedure kit, non-medicated, reusable", from 34 companies. The largest labeler is Medline Industries, Inc. with 97% of records.

Which FDA product codes apply?

LRO (General surgery tray), FDE (laparoscopy kit), OEZ (Cardiovascular procedure kit), OES (Cardiac catheterization kit)

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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