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Non Autoclavable Plastic Ocular Shield regular, In Bulk
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- Non Autoclavable Plastic Ocular Shield regular, In Bulk FDA UDI
- Generic Name
- Radiation/mechanical corneal shield, single-use FDA UDI
- Device Name
- The plastic ocular shields are used to protect the eyes when working with a scalpel, electro-cutter or other energy sources requiring protective plastic shields as the metal would be conductive (ex: RF system). The ocular shields are inserted under the eyelids over the globe, and remain in place for the duration of the intervention. They should not be left in place more than 60 minutes. PLASTIC OCULAR SHIELDS ARE NOT INTENDED FOR USE WITH LASER OR IPL SYSTEMS. FDA UDI
- Model / Reference
- 21-204BV FDA UDI
- Description
- The plastic ocular shields are used to protect the eyes when working with a scalpel, electro-cutter or other energy sources requiring protective plastic shields as the metal would be conductive (ex: RF system). The ocular shields are inserted under the eyelids over the globe, and remain in place for the duration of the intervention. They should not be left in place more than 60 minutes. PLASTIC OCULAR SHIELDS ARE NOT INTENDED FOR USE WITH LASER OR IPL SYSTEMS. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 90697660001343 FDA UDI
- FDA Product Code
- HOY FDA UDI
- GMDN Term
- Radiation/mechanical corneal shield, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.4750 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Dimensions & Sizes
- Size
- Width — 24.5 Millimeter FDA UDILength — 27.5 Millimeter FDA UDI
Non Autoclavable Plastic Ocular Shield regular, In Bulk by Oculo-Plastik Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 |
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Manufacturer
- Manufacturer
- Oculo-Plastik Inc
Sources (1)
- FDA UDI 10ee05e7-8fd7-4568-80d7-3afd84803323 36 fields · synced Jun 1, 2026