X-Wool ®

FDA UDI

Class I (US FDA UDI)

by Knit-Rite, Inc

Identity

Trade Name: X-WOOL ® FDA UDI
Generic Name: Compression/pressure sock/stocking, single-use FDA UDI
Device Name: X-WOOL 5PLY EWMD 11-12" TOP 7-8" TOE X 16-18 FDA UDI
Model / Reference: 1WX5EWMD FDA UDI
Description: X-WOOL 5PLY EWMD 11-12" TOP 7-8" TOE X 16-18 FDA UDI

Identifiers

Catalog Number: 1WX5EWMD FDA UDI
Primary DI / UDI-DI: 00674854002109 FDA UDI
FDA Product Code: FQL FDA UDI
DWL FDA UDI
GMDN Term: Compression/pressure sock/stocking, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 880.5780 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

Yes

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

FDA UDI

Manufacturing Date

FDA UDI

Category: Compression/pressure sock/stocking, single-use

X-Wool ® by Knit-Rite, Inc — 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: Knit-Rite, Inc

Sources (1)

FDA UDI fae35936-3ca5-4337-ae07-8f6443b4df77 34 fields · synced Jun 8, 2026