ALLEVYN Ag Adhesive 3in x 3in 66020970

GUDID 05000223459789

ALLEVYN Ag Adhesive 3in x 3in Silver Wound Dressing

SMITH & NEPHEW MEDICAL LIMITED

Wound-nonadherent dressing, absorbent, antimicrobial
Primary Device ID05000223459789
NIH Device Record Key37ac7103-daa8-487e-aabb-4acc827f8f36
Commercial Distribution StatusIn Commercial Distribution
Brand NameALLEVYN Ag Adhesive 3in x 3in
Version Model Number66020970
Catalog Number66020970
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 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
GS105000223459772 [Primary]
GS105000223459789 [Package]
Contains: 05000223459772
Package: Carton [10 Units]
In Commercial Distribution
GS105000223459796 [Package]
Package: case [4 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FRODressing, Wound, Drug

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[05000223459789]

Radiation Sterilization


[05000223459789]

Radiation Sterilization


[05000223459789]

Radiation Sterilization


[05000223459789]

Radiation Sterilization


[05000223459789]

Radiation Sterilization


[05000223459789]

Radiation Sterilization


[05000223459789]

Radiation Sterilization


[05000223459789]

Radiation Sterilization


[05000223459789]

Radiation Sterilization


[05000223459789]

Radiation Sterilization


[05000223459789]

Radiation Sterilization


[05000223459789]

Radiation Sterilization


[05000223459789]

Radiation Sterilization


[05000223459789]

Radiation Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-05-18
Device Publish Date2019-07-04

Devices Manufactured by SMITH & NEPHEW MEDICAL LIMITED

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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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