Identity
- Trade Name
- Surgical Eye Shield FDA UDI
- Generic Name
- Surgical eye pressure shield FDA UDI
- Model / Reference
- Large Black FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00854428006874 FDA UDI
- FDA Product Code
- HOY FDA UDI
- GMDN Term
- Surgical eye pressure shield FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.4750 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Ethylene Oxide FDA UDI
Category: Surgical eye pressure shield
Surgical Eye Shield by Jardon Eye Prosthetics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical eye pressure shield.
- Eye Shield — Katena Products, Inc. · Class I
- Marina Medical — MARINA MEDICAL INSTRUMENTS, INC. · Class I
- Marina Medical — MARINA MEDICAL INSTRUMENTS, INC. · Class I
- Eye Shield — Katena Products, Inc. · Class I
- McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class I
- MSI Precision Specialty Instruments — Med Saver, Inc. · Class I
- SunMed — SunMed · Class I
- McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Jardon Eye Prosthetics, Inc.
Sources (1)
- FDA UDI 980fbe3a-b3a3-4ed1-8c6d-3a405591d8c3 32 fields · synced May 30, 2026