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LUTONIX® Drug Coated Balloon

FDA UDI

Class III (US FDA UDI)

by Lutonix

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" 130cm 4x100mm 5 French FDA UDI
Model / Reference
LX3513041005F FDA UDI
Description
LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 4x100mm 5 French FDA UDI

Identifiers

Catalog Number
LX3513041005F FDA UDI
Primary DI / UDI-DI
00801741123160 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
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

Category: Peripheral angioplasty balloon catheter, drug-coated

LUTONIX® Drug Coated Balloon by Lutonix — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Peripheral angioplasty balloon catheter, drug-coated.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Lutonix

Sources (1)

  • FDA UDI 28b3161b-3ede-448a-bd41-e617dc646e65 36 fields · synced May 30, 2026