Identity
- Trade Name
- VIDEO BRONCHOSCOPE FDA UDI
- Generic Name
- Flexible video bronchoscope, reusable FDA UDI
- Device Name
- VIDEO BRONCHOSCOPE 1.2C 3.8TP 600L (REFURBISHED) FDA UDI
- Model / Reference
- EB-1170K FDA UDI
- Description
- VIDEO BRONCHOSCOPE 1.2C 3.8TP 600L (REFURBISHED) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04961333232154 FDA UDI
- 510(k) Number
- K131028 FDA UDI
- FDA Product Code
- EOQ FDA UDI
- GMDN Term
- Flexible video bronchoscope, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.4680 FDA UDI
- Commercial Distribution
- 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
Category: Flexible video bronchoscope, reusable
Video Bronchoscope by PENTAX of America, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Flexible video bronchoscope, reusable.
- EVIS EXERA BRONCHOVIDEOSCOPE — Olympus Medical Systems Corporation · Class II
- FUJIFILM — FUJIFILM Corporation · Class I
- PENTAX Medical — HOYA CORPORATION · Class II
- PENTAX — HOYA CORPORATION · Class II
- FUJIFILM — FUJIFILM Corporation · Class I
- FUJIFILM — FUJIFILM Corporation · Class I
- EVIS EXERA II BRONCHOVIDEOSCOPE — Olympus Medical Systems Corporation · Class II
- EVIS EXERA II BRONCHOVIDEOSCOPE — Olympus Medical Systems Corporation · Class II
Cleared under the same submission
K131028 also covers:
- PENTAX — HOYA CORPORATION
- PENTAX — HOYA CORPORATION
- PENTAX — HOYA CORPORATION
- VIDEO BRONCHOSCOPE — PENTAX of America, Inc.
- VIDEO BRONCHOSCOPE — PENTAX of America, Inc.
- VIDEO BRONCHOSCOPE — PENTAX of America, Inc.
- VIDEO BRONCHOSCOPE — PENTAX of America, Inc.
- VIDEO BRONCHOSCOPE — PENTAX of America, Inc.
- VIDEO BRONCHOSCOPE — PENTAX of America, Inc.
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
- PENTAX of America, Inc.
Sources (1)
- FDA UDI 9aa76527-b946-4e4c-a226-5a1e9e93a978 34 fields · synced Jun 1, 2026