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Advazorb Lite

FDA UDI

Class I (US FDA UDI)

by Brightwake Limited

Identity

Trade Name
Advazorb Lite FDA UDI
Generic Name
Wound-nonadherent dressing, absorbent, non-antimicrobial FDA UDI
Device Name
Hydrophilic foam dressing with film backing, 15cm x 15cm. A soft, conforming non-adherent hydrophilic polyurethane foam wound dressing with pink polyurethane film backing. Advazorb Lite has high fluid absorbency and retention characteristics. FDA UDI
Model / Reference
CR4174 FDA UDI
Description
Hydrophilic foam dressing with film backing, 15cm x 15cm. A soft, conforming non-adherent hydrophilic polyurethane foam wound dressing with pink polyurethane film backing. Advazorb Lite has high fluid absorbency and retention characteristics. FDA UDI

Identifiers

Primary DI / UDI-DI
05060031474862 FDA UDI
FDA Product Code
NAC FDA UDI
GMDN Term
Wound-nonadherent dressing, absorbent, non-antimicrobial FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4018 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

Dimensions & Sizes

Size
Width — 15 Centimeter FDA UDI
Length — 15 Centimeter FDA UDI

Category: Wound-nonadherent dressing, absorbent, non-antimicrobial

Advazorb Lite by Brightwake Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Wound-nonadherent dressing, absorbent, non-antimicrobial.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Brightwake Limited

Sources (1)

  • FDA UDI 13d877d4-ad84-401a-bba0-78ee0f56035c 35 fields · synced May 30, 2026