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Lightbox Umbilical

FDA UDI

Class II (US FDA UDI)

by Avinger, Inc.

Identity

Trade Name
Lightbox Umbilical FDA UDI
Generic Name
Mechanical atherectomy system generator, mechanical output FDA UDI
Device Name
Lightbox Umbilical is intended for use in peripheral vascular procedures in conjunction with a compatible Avinger product. FDA UDI
Model / Reference
U250 FDA UDI
Description
Lightbox Umbilical is intended for use in peripheral vascular procedures in conjunction with a compatible Avinger product. FDA UDI

Identifiers

Catalog Number
U250 FDA UDI
Primary DI / UDI-DI
00851354004301 FDA UDI
FDA Product Code
NQQ FDA UDI
GMDN Term
Mechanical atherectomy system generator, mechanical output FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1560 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

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Mechanical atherectomy system generator, mechanical output

Lightbox Umbilical by Avinger, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Mechanical atherectomy system generator, mechanical output.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Avinger, Inc.

Sources (1)

  • FDA UDI ac2def24-cf8f-4d6b-96d5-f8e8c00df2a1 35 fields · synced May 30, 2026