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Device Explorer · FDA GUDID · GMDN 44711

Optical medical device procedural cover

A device designed to fit over the distal end of a non-surgically-invasive device with optical functionality (e.g., laser beam-guide, optical scanning handpiece, endoscope) during use, to act as a cover/shield to avoid direct contact to the eye and/or cross-con

US‑registered devices91in commercial distribution
Companies11labelers on GUDID
Single‑use99%of device records
Sterile96%labelled sterile
Prescription80%Rx‑only share
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Share of device records

Medtronic Xomed, Inc.6268%
Cogentix Medical, Inc.1719%
Intuitive Surgical, Inc.33%
Suretek Medical22%
Led Dental Inc11%
Carl Zeiss Meditec Ag11%
Eon Meditech Private Limited11%
Microlight Corporation Of America11%

Top labelers

CompanyDevicesShare
Medtronic Xomed, Inc.6268%
Cogentix Medical, Inc.1719%
Intuitive Surgical, Inc.33%
Suretek Medical22%
Led Dental Inc11%
Carl Zeiss Meditec Ag11%
Eon Meditech Private Limited11%
Microlight Corporation Of America11%
Osteomed Llc11%
Align Technology, Inc.11%
Clear Guide Medical, Inc.11%

Company = labeler of record on GUDID. 11 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

VELscopeSterile Sheath for CONVIVOOSSEOUS-Endoscrub 4 mm ( 0° )NoneEndoWristEndoSheath TechnologyML 830®OsteoMediTero Lumina 25 Disposable Sleeves BoxReprocessed 4mm EndoScrub Sheath, 70 deg, K StorReprocessed 4mm EndoScrub 2 Sheath, 0 deg, w/TubClear Guide SteriMASKSLIDE-ON® ENDOSHEATH®ENDO-SCRUB®SLIDE-ON®

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

FDA product codes

CodeNameDevices
EOBNASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)78
EOBNasopharyngoscope (flexible or rigid)27
EOQBronchoscope (Flexible Or Rigid)11
EOXESOPHAGOSCOPE (FLEXIBLE OR RIGID)7
NAYSystem, surgical, computer controlled instrument2
FAJCystoscope And Accessories, Flexible/Rigid2

GMDN & GCC registration

  • GMDN code 44711 · non‑implantable
  • Single‑use 99% · sterile 96% · Rx‑only 80% · OTC 1%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Angle (degree) · 47Lumen/Inner Diameter (Millimeter) · 35Length (Millimeter) · 10Width (Millimeter) · 2Outer Diameter (Millimeter) · 2

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

How many optical medical device procedural cover 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 "Optical medical device procedural cover", from 11 companies. The largest labeler is Medtronic Xomed, Inc. with 68% of records.

Which FDA product codes apply?

EOB (NASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)), EOB (Nasopharyngoscope (flexible or rigid)), EOQ (Bronchoscope (Flexible Or Rigid)), EOX (ESOPHAGOSCOPE (FLEXIBLE OR RIGID))

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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