KerraLite Cool Border

FDA UDI

Class I (US FDA UDI)

by Crawford Healthcare Limited

Identity

Trade Name: KerraLite Cool Border FDA UDI
Generic Name: Wound hydrogel dressing, non-antimicrobial FDA UDI
Model / Reference: 6x6in FDA UDI

Identifiers

Catalog Number: CWL1009 FDA UDI
Primary DI / UDI-DI: 05060077231283 FDA UDI
FDA Product Code: NAE FDA UDI
GMDN Term: Wound hydrogel dressing, non-antimicrobial FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4022 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

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

Dimensions & Sizes

Size: Length — 6 Inch FDA UDI
Height — 6 Inch FDA UDI

Category: Wound hydrogel dressing, non-antimicrobial

KerraLite Cool Border by Crawford Healthcare Limited — 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: Crawford Healthcare Limited

Sources (1)

FDA UDI 894e0c5b-5e92-41df-b756-1ee7a82f7b5a 36 fields · synced May 30, 2026