Identity
- Trade Name
- EverFlex FDA UDI
- Generic Name
- Peripheral artery stent, bare-metal FDA UDI
- Device Name
- STENT PRB35-06-100-120 PROTEGE EF V09 FDA UDI
- Model / Reference
- PRB35-06-100-120 FDA UDI
- Description
- STENT PRB35-06-100-120 PROTEGE EF V09 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00821684068748 FDA UDI
- PMA Number
- P110023 FDA UDI
- FDA Product Code
- NIP FDA UDI
- GMDN Term
- Peripheral artery stent, bare-metal FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
Dimensions & Sizes
- Size
- Length — 100.0 Millimeter FDA UDICatheter Gauge — 6.0 French FDA UDI
EverFlex by Ev3, Inc — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
P110023 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 III | Pending data |
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Manufacturer
- Manufacturer
- Ev3, Inc
Sources (1)
- FDA UDI c5964417-709b-4ae7-9fac-8071a215b008 37 fields · synced Jun 1, 2026