Identity
- Trade Name
- PENTAX FDA UDI
- Generic Name
- Endoscope air/water valve, reusable FDA UDI
- Device Name
- V-Ring For OF-B77/96/123/132 OF-B138 FDA UDI
- Model / Reference
- OF-B138 FDA UDI
- Description
- V-Ring For OF-B77/96/123/132 OF-B138 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04961333084456 FDA UDI
- 510(k) Number
- K963056 FDA UDI
- FDA Product Code
- FDT FDA UDI
- GMDN Term
- Endoscope air/water valve, reusable 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
K963056 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Hoya Corporation
Sources (1)
- FDA UDI 35efe0f7-5459-474d-b13e-642ab75a8bd0 35 fields · synced May 31, 2026