ComPel Surgical Gown 75612345

GUDID 00634916348491

ComPel Surg Gown 2-Ply Front/Sleeves of Beryl Green ComPel, 1-Ply Comfort Panel Back with Negastat, Color Coded ComPel Neck Binding, Tie Closure at Neck, Circumferentially Offset Sleeves, Overcast Safety Stitch Body, Large

STANDARD TEXTILE CO., INC.

Surgical gown, reusable Surgical gown, reusable Surgical gown, reusable Surgical gown, reusable Surgical gown, reusable Surgical gown, reusable Surgical gown, reusable Surgical gown, reusable Surgical gown, reusable Surgical gown, reusable Surgical gown, reusable Surgical gown, reusable Surgical gown, reusable Surgical gown, reusable Surgical gown, reusable Surgical gown, reusable Surgical gown, reusable Surgical gown, reusable Surgical gown, reusable Surgical gown, reusable Surgical gown, reusable Surgical gown, reusable Surgical gown, reusable Surgical gown, reusable Surgical gown, reusable Surgical gown, reusable Surgical gown, reusable Surgical gown, reusable Surgical gown, reusable Surgical gown, reusable Surgical gown, reusable Surgical gown, reusable Surgical gown, reusable Surgical gown, reusable Surgical gown, reusable Surgical gown, reusable Surgical gown, reusable Surgical gown, reusable Surgical gown, reusable Surgical gown, reusable Surgical gown, reusable Surgical gown, reusable Surgical gown, reusable Surgical gown, reusable Surgical gown, reusable Surgical gown, reusable Surgical gown, reusable Surgical gown, reusable
Primary Device ID00634916348491
NIH Device Record Key94be7ac9-d96c-4139-9d21-c35775a56a42
Commercial Distribution StatusIn Commercial Distribution
Brand NameComPel Surgical Gown
Version Model Number75612345
Catalog Number75612345
Company DUNS006999858
Company NameSTANDARD TEXTILE CO., INC.
Device Count24
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
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
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
GS100634916348491 [Primary]
GS110634916348498 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FYAGown, Surgical

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00634916348491]

Moist Heat or Steam Sterilization

[00634916348491]

Moist Heat or Steam Sterilization

[00634916348491]

Moist Heat or Steam Sterilization

[00634916348491]

Moist Heat or Steam Sterilization

[00634916348491]

Moist Heat or Steam Sterilization

[00634916348491]

Moist Heat or Steam Sterilization

[00634916348491]

Moist Heat or Steam Sterilization

[00634916348491]

Moist Heat or Steam Sterilization

[00634916348491]

Moist Heat or Steam Sterilization

[00634916348491]

Moist Heat or Steam Sterilization

[00634916348491]

Moist Heat or Steam Sterilization

[00634916348491]

Moist Heat or Steam Sterilization

[00634916348491]

Moist Heat or Steam Sterilization

[00634916348491]

Moist Heat or Steam Sterilization

[00634916348491]

Moist Heat or Steam Sterilization

[00634916348491]

Moist Heat or Steam Sterilization

[00634916348491]

Moist Heat or Steam Sterilization

[00634916348491]

Moist Heat or Steam Sterilization

[00634916348491]

Moist Heat or Steam Sterilization

[00634916348491]

Moist Heat or Steam Sterilization

[00634916348491]

Moist Heat or Steam Sterilization

[00634916348491]

Moist Heat or Steam Sterilization

[00634916348491]

Moist Heat or Steam Sterilization

[00634916348491]

Moist Heat or Steam Sterilization

[00634916348491]

Moist Heat or Steam Sterilization

[00634916348491]

Moist Heat or Steam Sterilization

[00634916348491]

Moist Heat or Steam Sterilization

[00634916348491]

Moist Heat or Steam Sterilization

[00634916348491]

Moist Heat or Steam Sterilization

[00634916348491]

Moist Heat or Steam Sterilization

[00634916348491]

Moist Heat or Steam Sterilization

[00634916348491]

Moist Heat or Steam Sterilization

[00634916348491]

Moist Heat or Steam Sterilization

[00634916348491]

Moist Heat or Steam Sterilization

[00634916348491]

Moist Heat or Steam Sterilization

[00634916348491]

Moist Heat or Steam Sterilization

[00634916348491]

Moist Heat or Steam Sterilization

[00634916348491]

Moist Heat or Steam Sterilization

[00634916348491]

Moist Heat or Steam Sterilization

[00634916348491]

Moist Heat or Steam Sterilization

[00634916348491]

Moist Heat or Steam Sterilization

[00634916348491]

Moist Heat or Steam Sterilization

[00634916348491]

Moist Heat or Steam Sterilization

[00634916348491]

Moist Heat or Steam Sterilization

[00634916348491]

Moist Heat or Steam Sterilization

[00634916348491]

Moist Heat or Steam Sterilization

[00634916348491]

Moist Heat or Steam Sterilization

[00634916348491]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-04-13
Device Publish Date2020-04-03

On-Brand Devices [ComPel Surgical Gown]

00634916386196COMPEL, BERYL GREEN, L, 2 PLY FRONT/SLV TTIES (SR19498)
00634916343274SURG GWN ULT CMP NEGA GREEN L - 2PLY FRT/SLV TIES NK/WST
00634916343250OR Gown ComPel NEG BK BLUE L/XL
00634916343236OR GWN CMPL MISTY XL - TT @ NK NEGAST BK (SR 13404)
00634916343175OR GWN CMPL BL L - TT @ NK NEGAST BK
00634916325881OR GWN COMPEL NEGA BL KAUM L - RM (98 8305) USE: 75656695
00634916318784SURG GWN COMPEL GREEN M - 2PLY FRT/SLV TTIES (SR 17948)
00634916318760SURG GWN COMPEL GREEN L - 2PLY FRT/SLV TTIES (SR 17948)
00634916302677OR GWN COMPEL NEGA KAUM BL 2XL - RM (98 8305) USE: 75656693
00634916298048OR GWN ULT COMPEL KAUM BL XL - RM (98 8305) USE: 75656694
00634916294989OR GOWN COMPEL NEG KAUM BLU L/XL - RM (98 8282) USE: 75658785
00634916284539SURG GWN COMPEL KAUM GREEN M - 2PLY FRT/SLV TTIES (SR 17593)
00634916230437OR GWN CMPL NEGA KAUM BL 3XL - RM (98 8203) USE: 75656692
00634916230420OR GWN CMP KAUM BL 2X - RM (98 8203) USE: 75658783
00634916230413OR GWN CMP KAUM BK BLU L/XL - RM (98 8203) USE: 75658785
00634916229998OR GWN ULT COMPEL NEGA BL 2XL - 2PLY FRT/SLV SNAP NK (SR16569)
00634916229981OR GWN ULT COMPEL NEGA BL XL - 2PLY FRT/SLV SNAP NK (SR16991)
00634916229974OR GWN ULT COMPEL NEGA BL L - 2PLY FRT/SLV SNAP NK (SR16991)
00634916227031SURGICAL COMPEL KAUM GREEN L - 2PLY FRT/SLV TTIES (SR 16820)
00634916188226OR GWN COMPEL KAUM BK BLU L/XL - RM (98 8131) USE: 75658785
00634916147636OR GWN CMP NEG BK BLUE L/XL - SHORT 2PLY MS @ NK W/BARCODE
00634916147629OR GWN CMP NEG BK KAU BLU L/XL - RM (98-8282) MEMORIAL HERMANN
00634916147605OR GWN COMPEL KAUM BLUE 3XL - RM (98-8282) MEMORIAL HERMANN
00634916146639OR GWN COMPEL NEG BK BLUE 3XL - 2PLY MS @ NK TIE WST W/BARCODE
00634916141894OR GWN CMP NEG BK BLUE 2XL - 2PLY MS @ NK TIE WST W/BARCODE
00634916141887OR GWN COMPEL NEG BK BLUE L/XL - 2PLY MS @ NK TIE WST W/BARCODE
00634916137224OR GWN ULT COMPEL NEGA BL 2XL - 1PLY FRT/SLV (SR 15877)
00634916137217OR GWN ULT COMPEL NEGA BL XL - 1PLY FRT/SLV (SR 15877)
00634916137163OR GWN ULT COMPEL NEGA BL L - 1PLY FRT/SLV (SR 15877)
00634916110159SURGICAL GOWN COMPEL BLUE L - 1PLY FRT/SLV (S/R 14987)
00634916108316OR GWN COMPEL NEGA KAUM BL L - RM (98 7779) USE: 75656695
00634916084184OR GOWN COMPEL NGA BK KAUM L/XL - RM (98 7434) USE:75658785 BLUE
00634916056310SURG GWN ULT CMPL NEGA BL 2XL - 2PLY FRT/SLV-BL NK-TIE NK/WST
00634916051650ENDOSCOPY GOWN COMPEL MISTY L - POLY TIE NK/WST (S/R 12568)
00634916048124OR GWN ULT CMPL XL KAU NEGA BL - RM (98 7181) USE: 75656694
00634916048117OR GWN ULT CMPL L KAUM NEGA BL - RM (98 7181) USE: 75656695
00634916043211OR GWN FULL BARRIER CEIL M - TT @ WST W/BCODE S/R 11940
00634916040043OR GWN CMPL NEGA BK BLUE L/XL - 2PLY (S/R 11851)
00634916033236SURG GWN ULT COMPEL NEGA BL L - 2PLY FRT/SLV-BL NK-TIE NK/WST
00634916033229SURG GWN ULT CMPL NEGA BL XL - 2PLY FRT/SLV-BL NK-TIE NK/WST
00634916028416OR GWN ULT CMPL NEGA BL XL - 2PLY FRT-MS @ NK/WST SR 11109
00634916026085SURG GWN ULT CMPL NEGA BL 2XL - RM (98 2969) USE: 75656693
00634916025262OR GWN FULL BARRIER GREEN XL - TT @ NK/WST W/BCODE S/R 10880
00634916024470SURGICAL GWN COMPEL BL 2XL - SNAP NK/TIE WST (S/R 10720)
00634916024456OR GWN CMPL NEGA BK BLUE 2XL - RM (98 8282) USE: 75658783
00634916024449OR GWN CMPL NEGA BK BLUE L/XL - RM (98 8282) USE: 75658785
00634916016741SURG GWN ULT CMPL NEGA BL XL - 2PLY FRT/SLV-BL NK-TIE NK/WST
00634916011296SURG GWN ULT CMP NEGA BL L IMP - 2PLY FRT/SLV-BL NK-TIE NK/WST
00634916010923OR GWN CMPL TEAL XL - MS NK-MS TIES @ WST S/R 9338Y
00634916006018OR GWN CMPL ULT NEGA BL 3XL - TT NK/WST 2PLY FRNT/SLV QCM 3
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