Identity
- Trade Name
- Lutonix® Drug Coated Balloon FDA UDI
- Generic Name
- Peripheral angioplasty balloon catheter, drug-coated FDA UDI
- Device Name
- LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 5x40mm FDA UDI
- Model / Reference
- LX3575540 FDA UDI
- Description
- LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 75cm 5x40mm FDA UDI
Identifiers
- Catalog Number
- LX3575540 FDA UDI
- Primary DI / UDI-DI
- 00801741087998 FDA UDI
- FDA Product Code
- ONU 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® Drug Coated Balloon 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 b32e5a7a-a661-4cc8-b3b6-9067d3017bcc 37 fields · synced May 31, 2026