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LUTONIX ® 035 Drug Coated Balloon PTA Catheter
FDA UDIClass III (US FDA UDI)
by Lutonix
Identity
- Trade Name
- LUTONIX ® 035 Drug Coated Balloon PTA Catheter FDA UDI
- Generic Name
- Peripheral angioplasty balloon catheter, drug-coated FDA UDI
- Device Name
- Lutonix® AV Drug Coated Balloon PTA Catheter 6x80x40 FDA UDI
- Model / Reference
- LX3540680V FDA UDI
- Description
- Lutonix® AV Drug Coated Balloon PTA Catheter 6x80x40 FDA UDI
Identifiers
- Catalog Number
- LX3540680V FDA UDI
- Primary DI / UDI-DI
- 00801741135156 FDA UDI
- FDA Product Code
- PRC FDA UDI
- GMDN Term
- Peripheral angioplasty balloon catheter, drug-coated 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
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
Yes
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
LUTONIX ® 035 Drug Coated Balloon PTA Catheter by Lutonix — Class III — 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 III | Pending data |
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Manufacturer
- Manufacturer
- Lutonix
Sources (1)
- FDA UDI f3e5eb3f-e7fe-48b5-88f8-e89acfba63d1 37 fields · synced May 30, 2026