ACTICOAT 4" X 8" 20201

GUDID 00040565121413

Silver-coated antimicrobial barrier dressing

SMITH & NEPHEW MEDICAL LIMITED

Wound-nonadherent dressing, absorbent, antimicrobial
Primary Device ID00040565121413
NIH Device Record Key276f0902-4248-452d-a756-898b36cb2961
Commercial Distribution StatusIn Commercial Distribution
Brand NameACTICOAT 4" X 8"
Version Model Number20201
Catalog Number20201
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100040565121413 [Package]
Contains: 05000223449797
Package: Carton [12 Units]
In Commercial Distribution
GS105000223449797 [Primary]
GS130040565121650 [Package]
Package: Case [4 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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