ACTICOAT 2"X2" 20601

GUDID 00040565122014

Silver-coated antimicrobial barrier dressing

SMITH & NEPHEW MEDICAL LIMITED

Wound-nonadherent dressing, absorbent, antimicrobial
Primary Device ID00040565122014
NIH Device Record Keyc8cd3205-ebb0-4837-8906-7a26221859cf
Commercial Distribution StatusIn Commercial Distribution
Brand NameACTICOAT 2"X2"
Version Model Number20601
Catalog Number20601
Company DUNS216344051
Company NameSMITH & NEPHEW MEDICAL LIMITED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100040565122014 [Package]
Contains: 05000223455576
Package: Carton [5 Units]
In Commercial Distribution
GS105000223455576 [Primary]
GS130040565122015 [Package]
Package: Case [20 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MGPDressing, Wound And Burn, Occlusive

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-24
Device Publish Date2020-07-16

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