Barrier Supreme Wrapper 216515E5

GUDID 00634916074970

WRAPPER BAR SUP 18X18 KAUM CBL - RM (98 7447) USE: 21651502

STANDARD TEXTILE CO., INC.

Sterilization packaging, reusable
Primary Device ID00634916074970
NIH Device Record Key4d9ff44d-7b6d-4719-9574-f2f42036d478
Commercial Distribution StatusIn Commercial Distribution
Brand NameBarrier Supreme Wrapper
Version Model Number216515E5
Catalog Number216515E5
Company DUNS006999858
Company NameSTANDARD TEXTILE CO., INC.
Device Count144
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone1-800-999-0400
EmailGUDID@standardtextile.com
Phone1-800-999-0400
EmailGUDID@standardtextile.com
Phone1-800-999-0400
EmailGUDID@standardtextile.com
Phone1-800-999-0400
EmailGUDID@standardtextile.com
Phone1-800-999-0400
EmailGUDID@standardtextile.com
Phone1-800-999-0400
EmailGUDID@standardtextile.com
Phone1-800-999-0400
EmailGUDID@standardtextile.com
Phone1-800-999-0400
EmailGUDID@standardtextile.com
Phone1-800-999-0400
EmailGUDID@standardtextile.com
Phone1-800-999-0400
EmailGUDID@standardtextile.com
Phone1-800-999-0400
EmailGUDID@standardtextile.com
Phone1-800-999-0400
EmailGUDID@standardtextile.com
Phone1-800-999-0400
EmailGUDID@standardtextile.com
Phone1-800-999-0400
EmailGUDID@standardtextile.com
Phone1-800-999-0400
EmailGUDID@standardtextile.com
Phone1-800-999-0400
EmailGUDID@standardtextile.com
Phone1-800-999-0400
EmailGUDID@standardtextile.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100634916074970 [Primary]
GS110634916074970 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FRGWrap, Sterilization

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00634916074970]

Moist Heat or Steam Sterilization

[00634916074970]

Moist Heat or Steam Sterilization

[00634916074970]

Moist Heat or Steam Sterilization

[00634916074970]

Moist Heat or Steam Sterilization

[00634916074970]

Moist Heat or Steam Sterilization

[00634916074970]

Moist Heat or Steam Sterilization

[00634916074970]

Moist Heat or Steam Sterilization

[00634916074970]

Moist Heat or Steam Sterilization

[00634916074970]

Moist Heat or Steam Sterilization

[00634916074970]

Moist Heat or Steam Sterilization

[00634916074970]

Moist Heat or Steam Sterilization

[00634916074970]

Moist Heat or Steam Sterilization

[00634916074970]

Moist Heat or Steam Sterilization

[00634916074970]

Moist Heat or Steam Sterilization

[00634916074970]

Moist Heat or Steam Sterilization

[00634916074970]

Moist Heat or Steam Sterilization

[00634916074970]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-11-08
Device Publish Date2018-01-29

On-Brand Devices [Barrier Supreme Wrapper]

00634916343137WRAPPER BARR SUP 18X18 CEIL BL - 1 PLY MERROWED LAVENDER THREAD
00634916343120WRAPPER BARR SUP 70X70 JADE - MERROWED W/BLUE THREAD
00634916343113WRAPPER BARR SUP 54X54 JADE - MERROWED W/BLUE THREAD
00634916134209WRAPPER BARR SUP KAUM 45X45 CEIL - RM (98 7931) USE: 21655002
00634916074970WRAPPER BAR SUP 18X18 KAUM CBL - RM (98 7447) USE: 21651502
00634916005554WRAPPER BARR SUP 54X72 MISTY - MERROWED W/SALMON THREAD W/QCM
00634916005547WRAPPER BARR SUP 54X54 MISTY - MERROWED W/BLUE THREAD W/QCM#2
00634916005530WRAPPER BARR SUP 45X45 MISTY - MERROWED W/WHITE THREAD Q/QCM2
00634916005523WRAPPER BARR SUP 35X35 MISTY - MERROWED W/BLUE THREAD W/QCM#2
00634916005516WRAPPER BARR SUP 23X23 MISTY - 1-PLY MERROWED W/GREEN THRD
00634916000986WRAPPER BARR SUP 70X70 CEIL BL - MERROWED W/BLUE THREAD W/QCM2
00634916000979WRAPPER BARR SUP 54X72 CEIL BL - MERROWED W/SALMON THREAD W/QCM
00634916000962WRAPPER BARR SUP 54X54 CEIL BL - MERROWED W/BLUE THREAD W/QCM#2
00634916000955WRAPPER BARR SUP 45X45 CEIL - MERROWED W/WHITE THREAD W/QCM2
00634916000948WRAPPER BARR SUP 35X35 CEIL BL - MERROWED W/BLUE THREAD W/QCM#2
00634916000931WRAPPER BARR SUP 30X30 CEIL BL - MERROWED W/PINK THREAD W/QCM#2
00634916000924WRAPPER BARR SUP 23X23 CEIL BL - MERROWED W/GREEN THREAD W/QCM2
00634916000917WRAPPER BARR SUP 54X72 JADE - MERROWED W/SALMON THREAD
00634916000900WRAPPER BARR SUP 45X45 JADE - MERROWED W/WHITE THREAD W/QCM2
00634916000894WRAPPER BARR SUP 35X35 JADE - MERROWED W/BLUE THREAD W/QCM#2
00634916000887WRAPPER BARR SUP 23X23 JADE - MERROWED W/GREEN THREAD W/QCM2
00634916000870WRAPPER BARR SUP 18X18 JADE - 1 PLY MERROWED W/LAVENDER THRD
00634916000863WRAPPER BARR SUP 70X70 MISTY - MERROWED W/BLUE THREAD W/QCM2
00634916000856WRAPPER BARR SUP 30X30 MISTY - MERROWED W/PINK THREAD W/QCM#2
00634916000849WRAPPER BARR SUP 18X18 MISTY - 1 PLY MERROWED W/LAVENDER THRD
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