Identity
- Trade Name
- BK 1/T, table version, trial lens case FDA UDI
- Generic Name
- Trial lens frame FDA UDI
- Device Name
- BK 1/T, table version, trial lens case FDA UDI
- Model / Reference
- 33180 FDA UDI
- Description
- BK 1/T, table version, trial lens case FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04049584001191 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 1/T, table version, trial lens case 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
Sources (1)
- FDA UDI 5857c5f6-cc25-4c31-8345-661a9b6ac9a1 35 fields · synced Jun 8, 2026