Identity
- Trade Name
- PENTAX FDA UDI
- Generic Name
- Device control handling knob FDA UDI
- Device Name
- R/L Deflection Control Knob Cover OE-B1 FDA UDI
- Model / Reference
- OE-B1 FDA UDI
- Description
- R/L Deflection Control Knob Cover OE-B1 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04961333079551 FDA UDI
- 510(k) Number
- K951574 FDA UDI
- FDA Product Code
- FDF FDA UDI
- GMDN Term
- Device control handling knob FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Pentax by Hoya Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K951574 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
- Hoya Corporation
Sources (1)
- FDA UDI 2df49b1c-78ea-4369-9d53-a99fbdd8ea4a 35 fields · synced Jun 1, 2026