Consulting Wallah › Device Explorer › Procedure kits & trays › Urological surgical procedure kit, medicated, sing
Device Explorer · FDA GUDID · GMDN 46416

Urological surgical procedure kit, medicated, single-use

A collection of various sterile urological surgical instruments, dressings, pharmaceuticals, and the necessary materials intended to be used to perform a urological surgical procedure; is not dedicated to a specific type of urological surgical procedure. This

US‑registered devices5,571in commercial distribution
Companies3labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription100%Rx‑only share
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Share of device records

Cardinal Health 200, Llc3,58064%
Avid Medical, Inc.1,98936%
Obp Corporation20%

Top labelers

CompanyDevicesShare
Cardinal Health 200, Llc3,58064%
Avid Medical, Inc.1,98936%
Obp Corporation20%

Company = labeler of record on GUDID. 3 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

CARDINAL HEALTHFLUID MANAGEMENT PACKHalyardHALYARDAVID TruCustom

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

FDA product codes

CodeNameDevices
NWUEndoscope introducer kit3,200
LROGeneral surgery tray2,045
NWUKit, introducer, endoscope106
FDElaparoscopy kit102
OJGNeurological tray23
PEVDialysis administration kit18

GMDN & GCC registration

  • GMDN code 46416 · non‑implantable
  • Single‑use 100% · sterile 100% · Rx‑only 100% · 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 urological surgical procedure kit, medicated, single-use products are registered in the US?

5,571 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Urological surgical procedure kit, medicated, single-use", from 3 companies. The largest labeler is Cardinal Health 200, Llc with 64% of records.

Which FDA product codes apply?

NWU (Endoscope introducer kit), LRO (General surgery tray), NWU (Kit, introducer, endoscope), 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.

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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