Identity
- Trade Name
- LifeSpan Quick Tapered ePTFE Vascular Graft FDA UDI
- Generic Name
- Synthetic vascular graft FDA UDI
- Device Name
- LifeSpan Quick Tapered ePTFE Vascular Graft FDA UDI
- Model / Reference
- QT46040 FDA UDI
- Description
- LifeSpan Quick Tapered ePTFE Vascular Graft FDA UDI
Identifiers
- Catalog Number
- QT46040 FDA UDI
- Primary DI / UDI-DI
- 00840663109494 FDA UDI
- 510(k) Number
- K130016 FDA UDI
- FDA Product Code
- DSY FDA UDI
- GMDN Term
- Synthetic vascular graft FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.3450 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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Safe FDA UDI
LifeSpan Quick Tapered ePTFE Vascular Graft by LeMaitre Vascular, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- LeMaitre Vascular, Inc.
Sources (1)
- FDA UDI e9dce375-aa82-43fb-97cb-b6b16ccdf849 37 fields · synced Jun 9, 2026