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Device Explorer · FDA GUDID · GMDN 61943

Surgical eye pressure shield

A non-sterile device intended to cover and mechanically protect the eyes of a patient during surgery to prevent potential ocular pressure hazards/injury associated with surgery (e.g., resulting from inadvertent pressure being applied to the eye by healthcare p

US‑registered devices79in commercial distribution
Companies15labelers on GUDID
Single‑use48%of device records
Sterile16%labelled sterile
Prescription33%Rx‑only share
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Share of device records

Jardon Eye Prosthetics, Inc.2127%
Marina Medical Instruments, Inc.1722%
Katena Products, Inc.1013%
Med Saver, Inc.79%
Sunmed, Llc56%
Surgistar, Inc.45%
Rumex International Corp.34%
Mckesson Medical-Surgical Inc.34%

Top labelers

CompanyDevicesShare
Jardon Eye Prosthetics, Inc.2127%
Marina Medical Instruments, Inc.1722%
Katena Products, Inc.1013%
Med Saver, Inc.79%
Sunmed, Llc56%
Surgistar, Inc.45%
Rumex International Corp.34%
Mckesson Medical-Surgical Inc.34%
Ambler Surgical Corp.23%
Gri Medical & Electronic Technology Co., Ltd.23%
H&H Medical Corporation11%
Bound Tree Medical, Llc11%

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

Brand names on the register (sample)

SURGISTARH&H Combat Eye SheildSurgical Eye ShieldSilicone ConformerEye ShieldMarina MedicalRumexCuraplexMSI Precision Specialty InstrumentsAmbler SurgicalAllesetOCULAR SHIELDSunMed LLCSunMedCombat Eye ShieldMcKesson

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 eyewea41
HOYShield, Eye, Ophthalmic (Including Sunlamp Protective Eyewea38
HQNConformer, Ophthalmic1

GMDN & GCC registration

  • GMDN code 61943 · non‑implantable
  • Single‑use 48% · sterile 16% · Rx‑only 33% · OTC 3%
  • 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 surgical eye pressure shield products are registered in the US?

79 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Surgical eye pressure shield", from 15 companies. The largest labeler is Jardon Eye Prosthetics, Inc. with 27% of records.

Which FDA product codes apply?

HOY (Shield, eye, ophthalmic (including sunlamp protective eyewea), HOY (Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewea), HQN (Conformer, Ophthalmic)

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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