REPLICaRE THIN4X4"(10X10CM) 66801237

GUDID 05000223480646

Thin hydrocolloid wound dressing

SMITH & NEPHEW MEDICAL LIMITED

Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial
Primary Device ID05000223480646
NIH Device Record Keya37b5a42-15c3-4fd3-b064-52e5613652a6
Commercial Distribution StatusIn Commercial Distribution
Brand NameREPLICaRE THIN4X4"(10X10CM)
Version Model Number66801237
Catalog Number66801237
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
GS105000223480639 [Primary]
GS105000223480639 [Primary]
GS105000223480639 [Primary]
GS105000223480639 [Primary]
GS105000223480639 [Primary]
GS105000223480639 [Primary]
GS105000223480639 [Primary]
GS105000223480639 [Primary]
GS105000223480639 [Primary]
GS105000223480639 [Primary]
GS105000223480639 [Primary]
GS105000223480639 [Primary]
GS105000223480639 [Primary]
GS105000223480639 [Primary]
GS105000223480646 [Package]
Contains: 05000223480639
Package: Carton [10 Units]
In Commercial Distribution
GS105000223480646 [Package]
Contains: 05000223480639
Package: Carton [10 Units]
In Commercial Distribution
GS105000223480646 [Package]
Contains: 05000223480639
Package: Carton [10 Units]
In Commercial Distribution
GS105000223480646 [Package]
Contains: 05000223480639
Package: Carton [10 Units]
In Commercial Distribution
GS105000223480646 [Package]
Contains: 05000223480639
Package: Carton [10 Units]
In Commercial Distribution
GS105000223480646 [Package]
Contains: 05000223480639
Package: Carton [10 Units]
In Commercial Distribution
GS105000223480646 [Package]
Contains: 05000223480639
Package: Carton [10 Units]
In Commercial Distribution
GS105000223480646 [Package]
Contains: 05000223480639
Package: Carton [10 Units]
In Commercial Distribution
GS105000223480646 [Package]
Contains: 05000223480639
Package: Carton [10 Units]
In Commercial Distribution
GS105000223480646 [Package]
Contains: 05000223480639
Package: Carton [10 Units]
In Commercial Distribution
GS105000223480646 [Package]
Contains: 05000223480639
Package: Carton [10 Units]
In Commercial Distribution
GS105000223480646 [Package]
Contains: 05000223480639
Package: Carton [10 Units]
In Commercial Distribution
GS105000223480646 [Package]
Contains: 05000223480639
Package: Carton [10 Units]
In Commercial Distribution
GS105000223480646 [Package]
Contains: 05000223480639
Package: Carton [10 Units]
In Commercial Distribution
GS105000223480653 [Package]
Package: Case [10 Units]
In Commercial Distribution
GS105000223480653 [Package]
Package: Case [10 Units]
In Commercial Distribution
GS105000223480653 [Package]
Package: Case [10 Units]
In Commercial Distribution
GS105000223480653 [Package]
Package: Case [10 Units]
In Commercial Distribution
GS105000223480653 [Package]
Package: Case [10 Units]
In Commercial Distribution
GS105000223480653 [Package]
Package: Case [10 Units]
In Commercial Distribution
GS105000223480653 [Package]
Package: Case [10 Units]
In Commercial Distribution
GS105000223480653 [Package]
Package: Case [10 Units]
In Commercial Distribution
GS105000223480653 [Package]
Package: Case [10 Units]
In Commercial Distribution
GS105000223480653 [Package]
Package: Case [10 Units]
In Commercial Distribution
GS105000223480653 [Package]
Package: Case [10 Units]
In Commercial Distribution
GS105000223480653 [Package]
Package: Case [10 Units]
In Commercial Distribution
GS105000223480653 [Package]
Package: Case [10 Units]
In Commercial Distribution
GS105000223480653 [Package]
Package: Case [10 Units]
In Commercial Distribution

FDA Product Code

NADDressing, Wound, Occlusive
NADDressing, Wound, Occlusive
NADDressing, Wound, Occlusive
NADDressing, Wound, Occlusive
NADDressing, Wound, Occlusive
NADDressing, Wound, Occlusive
NADDressing, Wound, Occlusive
NADDressing, Wound, Occlusive
NADDressing, Wound, Occlusive
NADDressing, Wound, Occlusive
NADDressing, Wound, Occlusive
NADDressing, Wound, Occlusive
NADDressing, Wound, Occlusive
NADDressing, Wound, Occlusive

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-10-15
Device Publish Date2020-10-07

Devices Manufactured by SMITH & NEPHEW MEDICAL LIMITED

00040565115313 - REPLICaRE 1.5X2.5IN (4X6CM)2020-10-15 Hydrocolloid wound dressing
00040565115726 - REPLICaRE 4X4IN (10X10CM)2020-10-15 Hydrocolloid wound dressing
00040565115733 - REPLICaRE 6X6IN (15X15CM)2020-10-15 Hydrocolloid wound dressing
00040565115740 - REPLICaRE 8X8IN (20X20CM)2020-10-15 Hydrocolloid wound dressing
00040565115856 - REPLICaRE THIN DRESS 2X2.75IN2020-10-15 Thin hydrocolloid wound dressing
00040565115863 - REPLICaRE THIN DRESS 3.5X5.5IN2020-10-15 Thin hydrocolloid wound dressing
00040565115870 - REPLICaRE THIN DRESS 6X8IN2020-10-15 Thin hydrocolloid wound dressing
00040565120713 - REPLICaRE ULTRa DRS 4X4IN2020-10-15 Advanced hydrocolloid dressing

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