Consulting Wallah › Device Explorer › Procedure kits & trays › Obstetrical/gynaecological surgical procedure kit,
Device Explorer · FDA GUDID · GMDN 60644

Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use

A collection of various sterile surgical instruments, dressings/drapes, and materials intended to be used during obstetrical/gynaecological surgery. The kit may be referred to as a procedure pack and is typically comprised of devices that individually are not

US‑registered devices18,288in commercial distribution
Companies18labelers on GUDID
Single‑use100%of device records
Sterile99%labelled sterile
Prescription99%Rx‑only share
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Share of device records

Cardinal Health 200, Llc14,96082%
Avid Medical, Inc.2,91916%
Aligned Medical Solutions1461%
Deroyal Industries, Inc.1401%
Haslam Medical, Inc.250%
Packroom Llc240%
Robinson Healthcare Limited180%
Morrison Medical, Ltd140%

Top labelers

CompanyDevicesShare
Cardinal Health 200, Llc14,96082%
Avid Medical, Inc.2,91916%
Aligned Medical Solutions1461%
Deroyal Industries, Inc.1401%
Haslam Medical, Inc.250%
Packroom Llc240%
Robinson Healthcare Limited180%
Morrison Medical, Ltd140%
Medical Action Industries Inc.130%
Medline Industries, Inc.120%
Robert Busse & Co., Inc.40%
Cardinal Health, Inc.30%

Company = labeler of record on GUDID. 18 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

InstrapacCARDINAL HEALTHLabor Guard Perianal StabilizerAligned Medical SolutionsBusse Hospital DisposablesBR Surgical, LLCNEGA Gyn Lap/Upper Laser *RFID PBNEGA Vaginal Delivery *RFID PBNEGA C-Section *RFID PBWellstar OB (157015)Wellstar C-Section (157013)Wellstar Gyn Lap (157009)Kennestone TVT & Vag HystMarshall Gyn LapMarshall Vaginal DeliveryHuntsville GYN ROBOTIC PACK

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

FDA product codes

CodeNameDevices
OHDGynecological laparoscopic kit5,845
OHMCesarean section tray3,831
OKVObstetrical kit3,810
MLSLabor and Delivery Kit1,609
OJFHysterectomy kit1,098
HCYCURETTE, UTERINE694

GMDN & GCC registration

  • GMDN code 60644 · non‑implantable
  • Single‑use 100% · sterile 99% · Rx‑only 99% · 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

Height (Millimeter) · 1Weight (Kilogram) · 1Width (Millimeter) · 1Depth (Millimeter) · 1Length (Millimeter) · 1

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

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

18,288 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, single-use", from 18 companies. The largest labeler is Cardinal Health 200, Llc with 82% of records.

Which FDA product codes apply?

OHD (Gynecological laparoscopic kit), OHM (Cesarean section tray), OKV (Obstetrical kit), MLS (Labor and Delivery 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.

How do I get quotes?

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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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