Identity
- Trade Name
- FIBER BRONCHOSCOPE FDA UDI
- Generic Name
- Flexible fibreoptic bronchoscope FDA UDI
- Device Name
- FIBER BRONCHOSCOPE TD5.9,CD2.8 (REFURBISHED) FDA UDI
- Model / Reference
- FB-18P FDA UDI
- Description
- FIBER BRONCHOSCOPE TD5.9,CD2.8 (REFURBISHED) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04961333232673 FDA UDI
- 510(k) Number
- K951199 FDA UDI
- FDA Product Code
- EOQ FDA UDI
- GMDN Term
- Flexible fibreoptic bronchoscope FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.4680 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Fiber Bronchoscope by PENTAX of America, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
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
- PENTAX of America, Inc.
Sources (1)
- FDA UDI fa29086b-c8a0-430c-b343-73ab9d20b0d2 35 fields · synced May 31, 2026