ACTICOAT FLEX7 2" x 2" 66800403

GUDID 00040565124469

Silver-coated antimicrobial barrier dressing

SMITH & NEPHEW MEDICAL LIMITED

Wound-nonadherent dressing, absorbent, antimicrobial Wound-nonadherent dressing, absorbent, antimicrobial Wound-nonadherent dressing, absorbent, antimicrobial Wound-nonadherent dressing, absorbent, antimicrobial Wound-nonadherent dressing, absorbent, antimicrobial Wound-nonadherent dressing, absorbent, antimicrobial Wound-nonadherent dressing, absorbent, antimicrobial Wound-nonadherent dressing, absorbent, antimicrobial Wound-nonadherent dressing, absorbent, antimicrobial Wound-nonadherent dressing, absorbent, antimicrobial Wound-nonadherent dressing, absorbent, antimicrobial Wound-nonadherent dressing, absorbent, antimicrobial Wound-nonadherent dressing, absorbent, antimicrobial Wound-nonadherent dressing, absorbent, antimicrobial
Primary Device ID00040565124469
NIH Device Record Key2ae92bd3-e8ad-4fc3-965c-41aeaee90c44
Commercial Distribution StatusIn Commercial Distribution
Brand NameACTICOAT FLEX7 2" x 2"
Version Model Number66800403
Catalog Number66800403
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
GS100040565124292 [Primary]
GS100040565124292 [Primary]
GS100040565124292 [Primary]
GS100040565124292 [Primary]
GS100040565124292 [Primary]
GS100040565124292 [Primary]
GS100040565124292 [Primary]
GS100040565124292 [Primary]
GS100040565124292 [Primary]
GS100040565124292 [Primary]
GS100040565124292 [Primary]
GS100040565124292 [Primary]
GS100040565124292 [Primary]
GS100040565124292 [Primary]
GS100040565124469 [Package]
Contains: 00040565124292
Package: Carton [5 Units]
In Commercial Distribution
GS100040565124469 [Package]
Contains: 00040565124292
Package: Carton [5 Units]
In Commercial Distribution
GS100040565124469 [Package]
Contains: 00040565124292
Package: Carton [5 Units]
In Commercial Distribution
GS100040565124469 [Package]
Contains: 00040565124292
Package: Carton [5 Units]
In Commercial Distribution
GS100040565124469 [Package]
Contains: 00040565124292
Package: Carton [5 Units]
In Commercial Distribution
GS100040565124469 [Package]
Contains: 00040565124292
Package: Carton [5 Units]
In Commercial Distribution
GS100040565124469 [Package]
Contains: 00040565124292
Package: Carton [5 Units]
In Commercial Distribution
GS100040565124469 [Package]
Contains: 00040565124292
Package: Carton [5 Units]
In Commercial Distribution
GS100040565124469 [Package]
Contains: 00040565124292
Package: Carton [5 Units]
In Commercial Distribution
GS100040565124469 [Package]
Contains: 00040565124292
Package: Carton [5 Units]
In Commercial Distribution
GS100040565124469 [Package]
Contains: 00040565124292
Package: Carton [5 Units]
In Commercial Distribution
GS100040565124469 [Package]
Contains: 00040565124292
Package: Carton [5 Units]
In Commercial Distribution
GS100040565124469 [Package]
Contains: 00040565124292
Package: Carton [5 Units]
In Commercial Distribution
GS100040565124469 [Package]
Contains: 00040565124292
Package: Carton [5 Units]
In Commercial Distribution
GS130040565124460 [Package]
Package: Case [20 Units]
In Commercial Distribution
GS130040565124460 [Package]
Package: Case [20 Units]
In Commercial Distribution
GS130040565124460 [Package]
Package: Case [20 Units]
In Commercial Distribution
GS130040565124460 [Package]
Package: Case [20 Units]
In Commercial Distribution
GS130040565124460 [Package]
Package: Case [20 Units]
In Commercial Distribution
GS130040565124460 [Package]
Package: Case [20 Units]
In Commercial Distribution
GS130040565124460 [Package]
Package: Case [20 Units]
In Commercial Distribution
GS130040565124460 [Package]
Package: Case [20 Units]
In Commercial Distribution
GS130040565124460 [Package]
Package: Case [20 Units]
In Commercial Distribution
GS130040565124460 [Package]
Package: Case [20 Units]
In Commercial Distribution
GS130040565124460 [Package]
Package: Case [20 Units]
In Commercial Distribution
GS130040565124460 [Package]
Package: Case [20 Units]
In Commercial Distribution
GS130040565124460 [Package]
Package: Case [20 Units]
In Commercial Distribution
GS130040565124460 [Package]
Package: Case [20 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FRODressing, Wound, Drug
FRODressing, Wound, Drug
FRODressing, Wound, Drug
FRODressing, Wound, Drug
FRODressing, Wound, Drug
FRODressing, Wound, Drug
FRODressing, Wound, Drug
FRODressing, Wound, Drug
FRODressing, Wound, Drug
FRODressing, Wound, Drug
FRODressing, Wound, Drug
FRODressing, Wound, Drug
FRODressing, Wound, Drug
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 Date2020-09-14
Device Publish Date2020-09-04

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30040565111842 - SKIN-PREP 4oz Spray US2020-09-14 Protective Spray
30040565112436 - REMOVE Adhesive Remover 8oz US2020-09-14 Universal adhesive remover wipe
00040565116730 - No-Sting SKIN-PREP Wipes2020-09-14 No-sting protective wipe
30040565116915 - REMOVE Adhesive Remover 220ml US2020-09-14 Universal adhesive remover
30040565117165 - UNI-Solve Adhesive Remover 8oz US2020-09-14 Adhesive remover
30040565117455 - Spray-On SKIN-PREP 118ml Spray US2020-09-14 Protective Spray

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