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Autoclavable Plastic Ocular Shield, bilateral, extra-small, black with handle
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 23-202BRef 23-202BHRef 23-201BH
Identity
- Trade Name
- Plastic Ocular Shield (small), black EUDAMEDPlastic Ocular Shield (small), black with handle EUDAMEDPlastic Ocular Shield (extra small), black with handle EUDAMEDAutoclavable Plastic Ocular Shield, bilateral, extra-small, black with handle FDA UDIAutoclavable Plastic Ocular Shield, bilateral, small, black with handle FDA UDIAutoclavable Plastic Ocular Shield, bilateral, small, black FDA UDI
- Generic Name
- Radiation/mechanical corneal shield, reusable FDA UDI
- Device Name
- Plastic Ocular Shield EUDAMEDThe 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
- 23-201BH EUDAMEDFDA UDI23-202BH EUDAMEDFDA UDI23-202B EUDAMEDFDA 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
- 10697660002641 EUDAMEDFDA UDI10697660002801 EUDAMEDFDA UDI10697660002788 EUDAMEDFDA UDI
- Basic UDI-DI
- 697660100US EUDAMED
- Direct Marketing DI
- 10697660002788 EUDAMED10697660002801 EUDAMED10697660002641 EUDAMED
- FDA Product Code
- HOY FDA UDI
- EMDN Code
- T0306 PATIENT PROTECTION DEVICES DURING CLINICAL PROCEDURES EUDAMED
- GMDN Term
- Radiation/mechanical corneal shield, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 886.4750 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
- Length — 23 Millimeter FDA UDIWidth — 21 Millimeter FDA UDIWidth — 23 Millimeter FDA UDILength — 25.5 Millimeter FDA UDIWidth — 23.5 Millimeter FDA UDILength — 26 Millimeter FDA UDI
Category: Radiation/mechanical corneal shield, reusable
Autoclavable Plastic Ocular Shield, bilateral, extra-small, 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 (6)
- FDA UDI 15003b00-90de-4055-b8e0-c9826aaed20b 35 fields · synced Jul 13, 2026
- FDA UDI e6231f04-442d-41c2-af79-68d20198747a 35 fields · synced May 29, 2026
- FDA UDI 7a5c6b7d-c92d-4f3a-a902-5f0f4e7640f7 35 fields · synced May 30, 2026
- EUDAMED bb10d015-50d1-49e7-b50e-5771a87633a4 61 fields · synced Jun 20, 2026
- EUDAMED 0b61b146-2f00-4f7e-b4ed-fc81e4156b5f 61 fields · synced Jul 10, 2026
- EUDAMED 5035449a-3cca-4479-b993-4f4b2e09065c 61 fields · synced Jul 13, 2026