Identity
- Trade Name
- BK 2, coated, wooden case with handle FDA UDI
- Generic Name
- Trial lens frame FDA UDI
- Device Name
- BK 2, coated, wooden case with handle FDA UDI
- Model / Reference
- 334801 FDA UDI
- Description
- BK 2, coated, wooden case with handle FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04049584001498 FDA UDI
- FDA Product Code
- HPC FDA UDI
- GMDN Term
- Trial lens frame FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.1405 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
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
Yes
FDA UDI
BK 2, coated, wooden case with handle by OCULUS Optikgeräte Gesellschaft mit beschränkter Haftung — Class I — FDA UDI — listed in FDA GUDID
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
Sources (1)
- FDA UDI 274c4695-7557-4722-9a37-5463fd1498c7 35 fields · synced May 31, 2026