Device Explorer · FDA GUDID · GMDN 37086

Endoscope sheath, reusable

A component of a rigid or flexible endoscope assembly designed as a tube through which an endoscope (e.g., hysteroscope) and endoscopic elements are introduced and assembled to create a complete operative endoscopic unit; it is also designed to function as a p

US‑registered devices2,662in commercial distribution
Companies35labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription75%Rx‑only share
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Share of device records

Surgical Direct, Inc.97737%
Karl Storz Gmbh & Co. Kg52020%
Sopro-Comeg Gmbh2048%
Richard Wolf Gmbh1656%
Arthrex, Inc.1415%
Joimax Gmbh733%
Conmed Corporation723%
National Advanced Endoscopy Devices, Inc.683%

Top labelers

CompanyDevicesShare
Surgical Direct, Inc.97737%
Karl Storz Gmbh & Co. Kg52020%
Sopro-Comeg Gmbh2048%
Richard Wolf Gmbh1656%
Arthrex, Inc.1415%
Joimax Gmbh733%
Conmed Corporation723%
National Advanced Endoscopy Devices, Inc.683%
Gyrus Acmi, Llc612%
Doppkon Gmbh & Co. Kg532%
Olympus Winter & Ibe Gmbh442%
Medos International Sàrl351%

Company = labeler of record on GUDID. 35 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

NAEDINTRAKENDOTRACRIGID SHEATH FOR LTF-190-10-3DN/AMaxMoreSpineUROLIFT ®Working Tube with Handle, long lipWorking Tube with Handle, oblique 35°Working Tube with Handle, Standard LipWorking Tube with long lipWorking tube, long lipOne-way valve for working tubeGuiding TubeWorking TubeEndoscope shaft

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

FDA product codes

CodeNameDevices
GCJLaparoscope, General & Plastic Surgery827
NBHAccessories, arthroscopic421
GCJLaparoscope, general & plastic surgery190
HIHHYSTEROSCOPE (AND ACCESSORIES)125
FAJCystoscope and accessories, flexible/rigid122
HIHHysteroscope (And Accessories)108

GMDN & GCC registration

  • GMDN code 37086 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 75% · 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

Outer Diameter (Millimeter) · 831Length (Centimeter) · 554Length (Millimeter) · 76Catheter Gauge (French) · 65Lumen/Inner Diameter (Millimeter) · 56Needle Gauge (Gauge) · 6

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

How many endoscope sheath, reusable products are registered in the US?

2,662 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Endoscope sheath, reusable", from 35 companies. The largest labeler is Surgical Direct, Inc. with 37% of records.

Which FDA product codes apply?

GCJ (Laparoscope, General & Plastic Surgery), NBH (Accessories, arthroscopic), GCJ (Laparoscope, general & plastic surgery), HIH (HYSTEROSCOPE (AND ACCESSORIES))

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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