Consulting Wallah › Device Explorer › Other devices › Radiation/mechanical corneal shield, reusable
Device Explorer · FDA GUDID · GMDN 64271

Radiation/mechanical corneal shield, reusable

A protective device intended to be placed on the cornea of a patient to protect the eyes from physical damage and/or exposure to primary and scattered radiation during a medical procedure [e.g., periorbital surgery, x-ray/CT scan, dermatological laser treatmen

US‑registered devices114in commercial distribution
Companies9labelers on GUDID
Single‑use11%of device records
Sterile4%labelled sterile
Prescription69%Rx‑only share
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Share of device records

Hayden Medical, Inc.2825%
Oculo-Plastik Inc2825%
Med Saver, Inc.2522%
Sontec Instruments, Inc.1614%
Black & Black Surgical, Inc.98%
Duckworth And Kent Limited54%
Noir Medical Technologies Llc11%
Surgical Direct, Inc.11%

Top labelers

CompanyDevicesShare
Hayden Medical, Inc.2825%
Oculo-Plastik Inc2825%
Med Saver, Inc.2522%
Sontec Instruments, Inc.1614%
Black & Black Surgical, Inc.98%
Duckworth And Kent Limited54%
Noir Medical Technologies Llc11%
Surgical Direct, Inc.11%
Integra Lifesciences Production Corporation11%

Company = labeler of record on GUDID. 9 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Duckworth & KentN/AHayden MedicalIshieldMSI Precision Specialty InstrumentsEye Shield With HandleEYE SHIELDCORNEAL EYE SHIELDSUCTION CUP SILICONE HANDLESurgical DirectAutoclavable Plastic Ocular Shield, bilateral, lAutoclavable Plastic Ocular Shield, bilateral, lAutoclavable Plastic Ocular Shield, bilateral, lAutoclavable Plastic Ocular Shield, bilateral, lAutoclavable Plastic Ocular Shield, bilateral, mAutoclavable Plastic Ocular Shield, bilateral, m

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

FDA product codes

CodeNameDevices
HOYShield, Eye, Ophthalmic (Including Sunlamp Protective Eyewea87
HOYShield, eye, ophthalmic (including sunlamp protective eyewea56
MOECollagen Corneal Shield23
HQHEYE, ARTIFICIAL, NON-CUSTOM9
HNIRetractor, Ophthalmic8
MOECollagen corneal shield4

GMDN & GCC registration

  • GMDN code 64271 · non‑implantable
  • Single‑use 11% · sterile 4% · Rx‑only 69% · 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) · 80Width (Millimeter) · 80Length (Inch) · 3Width (Inch) · 3Outer Diameter (Millimeter) · 1

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

How many radiation/mechanical corneal shield, reusable products are registered in the US?

114 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Radiation/mechanical corneal shield, reusable", from 9 companies. The largest labeler is Hayden Medical, Inc. with 25% of records.

Which FDA product codes apply?

HOY (Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewea), HOY (Shield, eye, ophthalmic (including sunlamp protective eyewea), MOE (Collagen Corneal Shield), HQH (EYE, ARTIFICIAL, NON-CUSTOM)

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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