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Autoclavable Plastic Ocular Shield, bilateral, medium, black with handle
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- Autoclavable Plastic Ocular Shield, bilateral, medium, black with handle FDA UDI
- Generic Name
- Radiation/mechanical corneal shield, reusable 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
- 23-204BH 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
- 10697660002962 FDA UDI
- FDA Product Code
- HOY FDA UDI
- GMDN Term
- Radiation/mechanical corneal shield, reusable 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
No
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
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Width — 24 Millimeter FDA UDILength — 27 Millimeter FDA UDI
Category: Radiation/mechanical corneal shield, reusable
Autoclavable Plastic Ocular Shield, bilateral, medium, black with handle by Oculo-Plastik Inc — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Oculo-Plastik Inc
Sources (2)
- FDA UDI 095da2dd-8d6b-45cb-851a-4f7800bd1cb0 35 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 19, 2026