Identity
- Trade Name
- Ion FDA UDI
- Generic Name
- Flexible video bronchoscope, reusable FDA UDI
- Device Name
- Catheter FDA UDI
- Model / Reference
- 490305 FDA UDI
- Description
- Catheter FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00886874124796 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Flexible video bronchoscope, reusable
Ion by Intuitive Surgical, 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
- VIDEO BRONCHOSCOPE — PENTAX of America, Inc. · Class II
- VIDEO BRONCHOSCOPE — PENTAX of America, Inc. · Class II
- FUJIFILM — FUJIFILM Corporation · Class I
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
- Intuitive Surgical, Inc.
Sources (1)
- FDA UDI d866d383-82f7-4b82-8721-b10ffece09d5 33 fields · synced Jun 9, 2026