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Acticoat 2"x2"

FDA UDI

Class U (US FDA UDI)

by Smith & Nephew Medical, Ltd.

Identity

Trade Name
ACTICOAT 2"X2" FDA UDI
Generic Name
Wound-nonadherent dressing, absorbent, antimicrobial FDA UDI
Device Name
Silver-coated antimicrobial barrier dressing FDA UDI
Model / Reference
20601 FDA UDI
Description
Silver-coated antimicrobial barrier dressing FDA UDI

Identifiers

Catalog Number
20601 FDA UDI
Primary DI / UDI-DI
05000223455576 FDA UDI
510(k) Number
K992221 FDA UDI
FDA Product Code
MGP FDA UDI
GMDN Term
Wound-nonadherent dressing, absorbent, antimicrobial FDA UDI

Classification

Device Class
U 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

Yes

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Wound-nonadherent dressing, absorbent, antimicrobial

Acticoat 2"x2" by Smith & Nephew Medical, Ltd. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

Cleared under the same submission

K992221 also covers:

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 c8cd3205-ebb0-4837-8906-7a26221859cf 35 fields · synced Jun 8, 2026