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Avaline Medical NJ LLC

FDA UDI

Class I (US FDA UDI)

by Avaline Medical NJ Limited Liability Company

Identity

Trade Name
Avaline Medical NJ LLC FDA UDI
Generic Name
Ankle binder, reusable FDA UDI
Device Name
Elastic Bandage Wrap with Self-Closure [Mixed Sizes Pack of 8] FDA UDI
Model / Reference
EBWx8 2EA FDA UDI
Description
Elastic Bandage Wrap with Self-Closure [Mixed Sizes Pack of 8] FDA UDI

Identifiers

Catalog Number
EBWx8 2EA FDA UDI
Primary DI / UDI-DI
00810077211236 FDA UDI
FDA Product Code
FQM FDA UDI
GMDN Term
Ankle binder, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
880.5075 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Ankle binder, reusable

Avaline Medical NJ LLC by Avaline Medical NJ Limited Liability Company — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Ankle binder, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Avaline Medical NJ Limited Liability Company

Sources (1)

  • FDA UDI ff394548-baeb-46f8-a772-291ceeb62cdf 35 fields · synced Jun 8, 2026