PRIMAPORE ADHESIVE DRESSING 10*8CM 66000317

GUDID 05000223420239

Non-woven adhesive wound dressing

SMITH & NEPHEW MEDICAL LIMITED

Adhesive bandage
Primary Device ID05000223420239
NIH Device Record Key6ca1cfbe-fad2-42bb-a9af-ba259dae730d
Commercial Distribution StatusIn Commercial Distribution
Brand NamePRIMAPORE ADHESIVE DRESSING 10*8CM
Version Model Number66000317
Catalog Number66000317
Company DUNS216344051
Company NameSMITH & NEPHEW MEDICAL LIMITED
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS105000223420222 [Primary]
GS105000223420239 [Package]
Contains: 05000223420222
Package: Carton [20 Units]
In Commercial Distribution
GS105000223420246 [Package]
Package: Case [10 Units]
In Commercial Distribution

FDA Product Code

KGXTape And Bandage, Adhesive

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-16
Device Publish Date2020-07-08

Devices Manufactured by SMITH & NEPHEW MEDICAL LIMITED

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00040565117744 - COVRSITE2026-01-27 CovRSite Dressing 6 x 6 CTN10
00040565120256 - COVRSITE2026-01-27 CovRSite Plus Dressing 4 x 4 CTN10
00040565120270 - COVRSITE2026-01-27 CovRSite Plus Dressing 6 x 6 CTN10
00500223504335 - NOVIX2026-01-21 NOVIX PRIMER AND CLEANSER 4OZ
05000223502713 - No Sting Skin Prep2025-12-04 NO-STING SKIN PREP SPRAY 28ML US
05000223499389 - RENASYS2025-10-01 RENASYS WOUND+ Dressing kit with AIRLOCK Technology with foam, large
05000223499396 - RENASYS2025-10-01 RENASYS WOUND+ Dressing kit with AIRLOCK Technology with foam, medium

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