ALLEVYN AG NON ADHESIVE 4X4" CTN10 66020978

GUDID 05000223459963

Non-Adhesive antimicrobial hydrocellular dressing

SMITH & NEPHEW MEDICAL LIMITED

Wound-nonadherent dressing, absorbent, antimicrobial
Primary Device ID05000223459963
NIH Device Record Key0d7de837-fcd7-41fa-bd38-ae2dda64d1f8
Commercial Distribution StatusIn Commercial Distribution
Brand NameALLEVYN AG NON ADHESIVE 4X4" CTN10
Version Model Number66020978
Catalog Number66020978
Company DUNS216344051
Company NameSMITH & NEPHEW MEDICAL LIMITED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
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
GS105000223459956 [Primary]
GS105000223459963 [Package]
Contains: 05000223459956
Package: Carton [10 Units]
In Commercial Distribution
GS105000223459970 [Package]
Package: Case [7 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FRODressing, Wound, Drug

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-25
Device Publish Date2020-05-15

Devices Manufactured by SMITH & NEPHEW MEDICAL LIMITED

05000223504151 - BIOBRANE2025-03-11 BIOBRANE DRESSING - SMALL GLOVE US
05000223504168 - BIOBRANE2025-03-11 BIOBRANE DRESSING - MEDIUM GLOVE US
05000223504175 - BIOBRANE2025-03-11 BIOBRANE DRESSING - LARGE GLOVE US
05000223504182 - BIOBRANE2025-03-11 BIOBRANE DRESSING - PEDIATRIC GLOVE US
05000223504113 - BIOBRANE2025-03-10 BIOBRANE DRESSING 5.1INX5.1IN CTN 5 US
05000223504137 - BIOBRANE2025-03-10 BIOBRANE DRESSING 9.8INX15IN CTN 1 US
05000223504144 - BIOBRANE2025-03-10 BIOBRANE DRESSING 15INX19.7IN CTN 1 US
05000223504120 - BIOBRANE2025-03-07 BIOBRANE DRESSING 5.1INX15IN CTN 5 (US)

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