Consulting Wallah › Device Explorer › Procedure kits & trays › Laparoscopic surgical procedure kit, non-medicated
Device Explorer · FDA GUDID · GMDN 44096

Laparoscopic surgical procedure kit, non-medicated, single-use

A collection of various sterile laparoscopic and surgical instruments (e.g., access cannulae, forceps), dressings, and additional materials intended to be used specifically to perform a laparoscopic surgical procedure. It does not contain pharmaceuticals. It m

US‑registered devices10,224in commercial distribution
Companies15labelers 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, Llc9,77896%
Aligned Medical Solutions1562%
Deroyal Industries, Inc.1401%
Ethicon Endo-Surgery, Llc901%
Conmed Corporation200%
Packroom Llc150%
Smith & Nephew, Inc.100%
Aesculap Ag40%

Top labelers

CompanyDevicesShare
Cardinal Health 200, Llc9,77896%
Aligned Medical Solutions1562%
Deroyal Industries, Inc.1401%
Ethicon Endo-Surgery, Llc901%
Conmed Corporation200%
Packroom Llc150%
Smith & Nephew, Inc.100%
Aesculap Ag40%
Encision, Inc.40%
Medline Industries, Inc.20%
Novadaq Technologies Inc10%
Josnoe Medical, Inc.10%

Company = labeler of record on GUDID. 15 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

AESCULAPNA460P450PCARDINAL HEALTH560P660500XLPINPOINT PAQ®Aligned Medical SolutionsJosNoe Medical IncNEGA Gen Lap *RFID PBWellstar Gyn LapWellstar LaparoscopyWellstar Lap ColonKennestone Laparoscopic

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

FDA product codes

CodeNameDevices
FDElaparoscopy kit5,455
OHDGynecological laparoscopic kit3,217
NWUEndoscope introducer kit784
FDELaparoscopy Kit281
OJFHysterectomy kit279
OHDGynecological Laparoscopic Kit97

GMDN & GCC registration

  • GMDN code 44096 · 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

Length (Millimeter) · 19Outer Diameter (Millimeter) · 17Width (Millimeter) · 10

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

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

10,224 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Laparoscopic surgical procedure kit, non-medicated, single-use", from 15 companies. The largest labeler is Cardinal Health 200, Llc with 96% of records.

Which FDA product codes apply?

FDE (laparoscopy kit), OHD (Gynecological laparoscopic kit), NWU (Endoscope introducer kit), FDE (Laparoscopy 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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