REPLICaRE ULTRa SaCRUM 59484900

GUDID 00040565120805

Advanced hydrocolloid 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 ID00040565120805
NIH Device Record Key97fbfaf5-5e93-4495-bc6d-da277b414503
Commercial Distribution StatusIn Commercial Distribution
Brand NameREPLICaRE ULTRa SaCRUM
Version Model Number59484900
Catalog Number59484900
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
GS100040565120799 [Primary]
GS100040565120799 [Primary]
GS100040565120799 [Primary]
GS100040565120799 [Primary]
GS100040565120799 [Primary]
GS100040565120799 [Primary]
GS100040565120799 [Primary]
GS100040565120799 [Primary]
GS100040565120799 [Primary]
GS100040565120799 [Primary]
GS100040565120799 [Primary]
GS100040565120799 [Primary]
GS100040565120799 [Primary]
GS100040565120799 [Primary]
GS100040565120805 [Package]
Contains: 00040565120799
Package: Carton [5 Units]
In Commercial Distribution
GS100040565120805 [Package]
Contains: 00040565120799
Package: Carton [5 Units]
In Commercial Distribution
GS100040565120805 [Package]
Contains: 00040565120799
Package: Carton [5 Units]
In Commercial Distribution
GS100040565120805 [Package]
Contains: 00040565120799
Package: Carton [5 Units]
In Commercial Distribution
GS100040565120805 [Package]
Contains: 00040565120799
Package: Carton [5 Units]
In Commercial Distribution
GS100040565120805 [Package]
Contains: 00040565120799
Package: Carton [5 Units]
In Commercial Distribution
GS100040565120805 [Package]
Contains: 00040565120799
Package: Carton [5 Units]
In Commercial Distribution
GS100040565120805 [Package]
Contains: 00040565120799
Package: Carton [5 Units]
In Commercial Distribution
GS100040565120805 [Package]
Contains: 00040565120799
Package: Carton [5 Units]
In Commercial Distribution
GS100040565120805 [Package]
Contains: 00040565120799
Package: Carton [5 Units]
In Commercial Distribution
GS100040565120805 [Package]
Contains: 00040565120799
Package: Carton [5 Units]
In Commercial Distribution
GS100040565120805 [Package]
Contains: 00040565120799
Package: Carton [5 Units]
In Commercial Distribution
GS100040565120805 [Package]
Contains: 00040565120799
Package: Carton [5 Units]
In Commercial Distribution
GS100040565120805 [Package]
Contains: 00040565120799
Package: Carton [5 Units]
In Commercial Distribution
GS130040565120806 [Package]
Package: Case [6 Units]
In Commercial Distribution
GS130040565120806 [Package]
Package: Case [6 Units]
In Commercial Distribution
GS130040565120806 [Package]
Package: Case [6 Units]
In Commercial Distribution
GS130040565120806 [Package]
Package: Case [6 Units]
In Commercial Distribution
GS130040565120806 [Package]
Package: Case [6 Units]
In Commercial Distribution
GS130040565120806 [Package]
Package: Case [6 Units]
In Commercial Distribution
GS130040565120806 [Package]
Package: Case [6 Units]
In Commercial Distribution
GS130040565120806 [Package]
Package: Case [6 Units]
In Commercial Distribution
GS130040565120806 [Package]
Package: Case [6 Units]
In Commercial Distribution
GS130040565120806 [Package]
Package: Case [6 Units]
In Commercial Distribution
GS130040565120806 [Package]
Package: Case [6 Units]
In Commercial Distribution
GS130040565120806 [Package]
Package: Case [6 Units]
In Commercial Distribution
GS130040565120806 [Package]
Package: Case [6 Units]
In Commercial Distribution
GS130040565120806 [Package]
Package: Case [6 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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