ALLEVYN AG SACRUM LARGE CTN10 66020984

GUDID 05000223459901

Adhesive antimicrobial hydrocellular sacrum dressing

SMITH & NEPHEW MEDICAL LIMITED

Wound-nonadherent dressing, absorbent, antimicrobial
Primary Device ID05000223459901
NIH Device Record Key91f82049-3518-4537-85f1-906b5e64db32
Commercial Distribution StatusIn Commercial Distribution
Brand NameALLEVYN AG SACRUM LARGE CTN10
Version Model Number66020984
Catalog Number66020984
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
GS105000223459895 [Primary]
GS105000223459901 [Package]
Contains: 05000223459895
Package: Carton [10 Units]
In Commercial Distribution
GS105000223459918 [Package]
Package: Case [8 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

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