PROFORE KIT LF ANKLE CIRC 18-25CM Case 8

FDA UDI

Class I (US FDA UDI)

by Smith & Nephew Medical, Ltd.

Identity

Trade Name: PROFORE KIT LF ANKLE CIRC 18-25CM Case 8 FDA UDI
Generic Name: Wound dressing kit, non-medicated FDA UDI
Device Name: Multi-Layer Compression Bandage System. Latex Free formulation. FDA UDI
Model / Reference: 66000770 FDA UDI
Description: Multi-Layer Compression Bandage System. Latex Free formulation. FDA UDI

Identifiers

Catalog Number: 66000770 FDA UDI
Primary DI / UDI-DI: 05031844013876 FDA UDI
FDA Product Code: FQM FDA UDI
GMDN Term: Wound dressing kit, non-medicated 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

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Wound dressing kit, non-medicated

PROFORE KIT LF ANKLE CIRC 18-25CM Case 8 by Smith & Nephew Medical, Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 I	Pending data

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Manufacturer

Manufacturer: Smith & Nephew Medical, Ltd.

Sources (1)

FDA UDI 5732ee3c-cdbe-42c3-aafb-379c9a2334d2 34 fields · synced May 30, 2026