Identity
- Trade Name
- LifeStream FDA UDI
- Generic Name
- Peripheral artery endovascular stent-graft, non-medicated FDA UDI
- Device Name
- LifeStream™ Balloon Expandable Vascular Covered Stent, 6 mm x 16 mm, 80 cm catheter length FDA UDI
- Model / Reference
- LSMU0800616 FDA UDI
- Description
- LifeStream™ Balloon Expandable Vascular Covered Stent, 6 mm x 16 mm, 80 cm catheter length FDA UDI
Identifiers
- Catalog Number
- LSMU0800616 FDA UDI
- Primary DI / UDI-DI
- 05391522081420 FDA UDI
- FDA Product Code
- PRL FDA UDI
- GMDN Term
- Peripheral artery endovascular stent-graft, non-medicated FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Category: Peripheral artery endovascular stent-graft, non-medicated
LifeStream by ClearStream Technologies , Ltd. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Peripheral artery endovascular stent-graft, non-medicated.
- GORE VIABAHN Endoprosthesis — W. L. GORE & ASSOCIATES, INC · Class III
- iCast Covered Stent System, 8mmX38mmX80cm — Atrium Medical Corp. · Class III
- GORE VIABAHN Endoprosthesis — W. L. GORE & ASSOCIATES, INC · Class III
- GORE VIABAHN Endoprosthesis — W. L. GORE & ASSOCIATES, INC · Class III
- Fluency® Endovascular Stent Graft — Bard Peripheral Vascular · Class III
- GORE VIABAHN Endoprosthesis — W. L. GORE & ASSOCIATES, INC · Class III
- iCast Covered Stent System, 5mmX16mmX120cm — Atrium Medical Corp. · Class III
- iCast Covered Stent System, 7mmX59mmX120cm — Atrium Medical Corp. · Class III
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
- ClearStream Technologies , Ltd.
Sources (1)
- FDA UDI 998a044b-c40d-4523-9967-b294aca4fa20 36 fields · synced May 30, 2026