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ALLEVYN Gentle Border Lite 7.5cm x 7.5cm

FDA UDI

Class I (US FDA UDI)

by Smith & Nephew Medical, Ltd.

Identity

Trade Name
ALLEVYN Gentle Border Lite 7.5cm x 7.5cm FDA UDI
Generic Name
Exudate-absorbent dressing, non-gel, non-antimicrobial FDA UDI
Device Name
ALLEVYN Gentle Border Lite 7.5cm x 7.5cm Silicone gel adhesive hydrocellular sacrum dressing FDA UDI
Model / Reference
66020412 FDA UDI
Description
ALLEVYN Gentle Border Lite 7.5cm x 7.5cm Silicone gel adhesive hydrocellular sacrum dressing FDA UDI

Identifiers

Catalog Number
66020412, 66800834 FDA UDI
Primary DI / UDI-DI
05000223475468 FDA UDI
FDA Product Code
NAD FDA UDI
GMDN Term
Exudate-absorbent dressing, non-gel, non-antimicrobial FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4020 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

No

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

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Exudate-absorbent dressing, non-gel, non-antimicrobial

ALLEVYN Gentle Border Lite 7.5cm x 7.5cm by Smith & Nephew Medical, Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Exudate-absorbent dressing, non-gel, non-antimicrobial.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Smith & Nephew Medical, Ltd.

Sources (1)

  • FDA UDI f02f0871-2bb9-411d-a40e-ad6f97e6e641 34 fields · synced Jun 1, 2026