DURAFIBER Ag 10x12cm 66800571

GUDID 05000223467906

Absorbent gelling silver fibrous dressing

SMITH & NEPHEW MEDICAL LIMITED

Exudate-absorbent dressing, hydrophilic-gel, antimicrobial
Primary Device ID05000223467906
NIH Device Record Key36bd1385-9ed2-4bed-bf0e-382598943f48
Commercial Distribution StatusIn Commercial Distribution
Brand NameDURAFIBER Ag 10x12cm
Version Model Number66800571
Catalog Number66800571
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
GS105000223467890 [Primary]
GS105000223467906 [Package]
Contains: 05000223467890
Package: Carton [10 Units]
In Commercial Distribution
GS105000223467913 [Package]
Package: Case [12 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 StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2021-07-22
Device Publish Date2020-09-18

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