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Eckardt temporary keratoprosthesis, Ø 7 mm, 1.6mm depth
FDA UDIClass II (US FDA UDI)
by D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
Identity
- Trade Name
- Eckardt temporary keratoprosthesis, Ø 7 mm, 1.6mm depth FDA UDI
- Generic Name
- Therapeutic contact lens FDA UDI
- Model / Reference
- 1285.2 FDA UDI
Identifiers
- Catalog Number
- 1285.2 FDA UDI
- Primary DI / UDI-DI
- 08717872004549 FDA UDI
- FDA Product Code
- MLP FDA UDI
- GMDN Term
- Therapeutic contact lens FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.3400 FDA UDI
- Commercial Distribution
- Not 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
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Eckardt temporary keratoprosthesis, Ø 7 mm, 1.6mm depth by D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. — Class II — FDA UDI — listed in FDA…
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
Sources (1)
- FDA UDI bea72901-cf28-4c31-94ca-1f37d834edc8 34 fields · synced May 30, 2026