ACTICOAT 4"X48" 20501

GUDID 00040565121536

Silver-coated antimicrobial barrier dressing

SMITH & NEPHEW MEDICAL LIMITED

Wound-nonadherent dressing, absorbent, antimicrobial
Primary Device ID00040565121536
NIH Device Record Key6d76d004-f4b5-4fc6-acb8-7ec620c9f6b1
Commercial Distribution StatusIn Commercial Distribution
Brand NameACTICOAT 4"X48"
Version Model Number20501
Catalog Number20501
Company DUNS216344051
Company NameSMITH & NEPHEW MEDICAL LIMITED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
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
GS100040565121536 [Package]
Contains: 05000223449889
Package: Carton [6 Units]
In Commercial Distribution
GS105000223449889 [Primary]
GS130040565121681 [Package]
Package: Case [2 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 StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2021-06-22
Device Publish Date2020-09-18

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