Identity
- Trade Name
- Ocu-Film® +" FDA UDI
- Generic Name
- Ophthalmic tonometer tip cover FDA UDI
- Model / Reference
- 230653 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00812559012485 FDA UDI
- 510(k) Number
- K070534 FDA UDI
- FDA Product Code
- HKY FDA UDI
- GMDN Term
- Ophthalmic tonometer tip cover FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.1930 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
Yes
FDA UDI
Prescription Use
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Ophthalmic tonometer tip cover
Ocu-Film® +" by Reichert Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Ophthalmic tonometer tip cover.
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- Ocu-Film® +" — REICHERT INC. · Class II
Cleared under the same submission
K070534 also covers:
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 II | Pending data |
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Manufacturer
- Manufacturer
- Reichert Inc.
Sources (1)
- FDA UDI f513fe50-400a-4119-bc06-fcb64166a8cf 33 fields · synced May 30, 2026