Consulting Wallah › Device Explorer › Procedure kits & trays › Obstetrical/gynaecological surgical procedure kit,
Device Explorer · FDA GUDID · GMDN 44061

Obstetrical/gynaecological surgical procedure kit, non-medicated, reusable

A collection of various surgical instruments, dressings, and materials intended to be used during obstetrical/gynaecological surgery. It is a general-purpose obstetrical/gynaecological surgical kit, and as such is not dedicated to a specific type of surgical p

US‑registered devices91in commercial distribution
Companies2labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription93%Rx‑only share
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Share of device records

Elmed Incorporated8391%
Avalign Technologies, Inc.89%

Top labelers

CompanyDevicesShare
Elmed Incorporated8391%
Avalign Technologies, Inc.89%

Company = labeler of record on GUDID. 2 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

ELMEDELMED INCORPORATEDMillennium

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

FDA product codes

CodeNameDevices
GDGHook, Surgical, General & Plastic Surgery34
HDEHook, Fibroid, Gynecological19
HCYCurette, Uterine16
LKFCannula, Manipulator/Injector, Uterine9
HFBForceps, Biopsy, Gynecological9
HCZForceps, Surgical, Gynecological2

GMDN & GCC registration

  • GMDN code 44061 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 93% · 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

No structured size data on the register.

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

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

91 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Obstetrical/gynaecological surgical procedure kit, non-medicated, reusable", from 2 companies. The largest labeler is Elmed Incorporated with 91% of records.

Which FDA product codes apply?

GDG (Hook, Surgical, General & Plastic Surgery), HDE (Hook, Fibroid, Gynecological), HCY (Curette, Uterine), LKF (Cannula, Manipulator/Injector, Uterine)

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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