ComPel MLR Surgical Gown

GUDID 10634916797173

Surgical GWN MLR CMPL 2-Ply Front/Sleeves Aqua Compel MLR and White Compel MLR w/Negastat, 1-Ply Aqua MLR Comfort Panel Backs, 2XL

STANDARD TEXTILE CO., INC.

Surgical gown, reusable
Primary Device ID10634916797173
NIH Device Record Key1e4d20df-fe7c-4a31-8b48-faef5033a620
Commercial Distribution StatusIn Commercial Distribution
Brand NameComPel MLR Surgical Gown
Version Model Number75674913
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100634916797176 [Primary]
GS110634916797173 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FYAGown, Surgical

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10634916797173]

Moist Heat or Steam Sterilization

[10634916797173]

Moist Heat or Steam Sterilization

[10634916797173]

Moist Heat or Steam Sterilization

[10634916797173]

Moist Heat or Steam Sterilization

[10634916797173]

Moist Heat or Steam Sterilization

[10634916797173]

Moist Heat or Steam Sterilization

[10634916797173]

Moist Heat or Steam Sterilization

[10634916797173]

Moist Heat or Steam Sterilization

[10634916797173]

Moist Heat or Steam Sterilization

[10634916797173]

Moist Heat or Steam Sterilization

[10634916797173]

Moist Heat or Steam Sterilization

[10634916797173]

Moist Heat or Steam Sterilization

[10634916797173]

Moist Heat or Steam Sterilization

[10634916797173]

Moist Heat or Steam Sterilization

[10634916797173]

Moist Heat or Steam Sterilization

[10634916797173]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-06-17
Device Publish Date2021-06-09

On-Brand Devices [ComPel MLR Surgical Gown]

00634916311921OR GWN CMPL MLR KAUM AQUA 2XL - RM (98 8130) USE: 75670243
00634916310245OR Gown ComPel MLR 2PLY AQUA 4XL - SNPS @ NK/TT WST
00634916298765OR GWN CMPL MLR KAUM AQUA XL - RM (98 8130) USE: 7567R244
00634916298673OR GWN CMPL MLR 2PLY AQUA XL
00634916296884OR GWN CMPL MLR KAUM AQUA L - RM (98 8130) USE: 7567R245
00634916294880OR GOWN COMPEL MLR 2PLY AQUA L
00634916249101OR GWN COMPEL MLR 2PLY AQUA L/XL
00634916247305OR GWN CMPL MLR KAUM AQUA L - RM (98 7806) USE: 7567B215
00634916191899OR GWN CMPL MLR KAUM AQUA L/XL - RM (98 8130) USE:7567B2R4
00634916191769OR GWN CMPL MLR 2PLY AQUA L/XL
00634916187618OR GWN COMPL MLR KAUM AQUA 2XL - RM (98 8130) USE: 7567B163
00634916187601OR GWN COMPEL MLR KAUM AQUA XL - RM (98 8130) USE: 7567B164
00634916187595OR GWN COMPEL MLR KAUM AQUA L - RM (98 8130) USE: 7567B165
00634916178968OR GWN CMPL ULT MLR AQUA 3XL - MS @ NK/WST
00634916110999OR GWN CMPL MLR 2PLY AQUA 2XL - SNPS @ NK/TT WST
00634916110982OR GWN CMPL MLR 2PLY AQUA XL - SNPS @ NK/TT WST
00634916098396OR GWN CMPL MLR AQUA 2XL/3XL - 2PLY MS @ NK/TT WST (SR 14686)
00634916088526SURGICAL GWN MLR CMPL AQUA XL - SNAP NK/TIE WST AQUA CUFFS
00634916074109OR GWN CMPL MLR 2PLY KAUM 2X A - RM (98 7647) USE: 7567B213
00634916074093OR GWN CMPL MLR 2PLY KAUM L AQ
00634916028058OR GWN CMPL MLR 2PLY AQUA 4XL - SNPS @ NK/TT WST W/INV SLVS
00634916011838OR GWN CMPL MLR 2PLY AQUA 2XL - SNPS @ NK/TT WST W/INV SLVS
00634916011821OR GWN CMPL MLR 2PLY AQUA XL - SNPS @ NK/TT WST W/INV SLVS
00634916011814OR GWN CMPL MLR 2PLY AQUA L - SNPS @ NK/TT WST W/INV SLVS
00634916011432OR GWN COMPEL MLR AQUA 2XL - 2PLY TT @ NK/WST W/INV SLVS
00634916011135OR GWN COMPEL MLR AQUA XL - 2PLY TT @ NK/WST W/INV SLVS
00634916011128OR GWN COMPEL MLR AQUA L - 2PLY TT @ NK/WST W/INV SLVS
00634916010282OR GWN CMPL ULT MLR AQUA 2XL - MS @ NK/WST
00634916010275OR GWN CMPL ULT MLR AQUA M - MS
00634916009620OR GWN CMPL ULT MLR AQUA L - MS @ NK/WST
00634916009613OR GWN CMPL ULT MLR AQUA XL - MS @ NK/WST
00634916709674ComPel MLR Surgical Gown, 2-Ply Front, Circumferentially Offset Sleeves, Aqua Compel MLR Outer S
00634916496963ComPel MLR Backless Pathology Gown, 1-Ply Front Aqua, 2-Ply sleeves, size XL
00634916496956ComPel MLR Backless Pathology Gown, 1-Ply Front Aqua, 2-Ply sleeves, size Medium
00634916496949ComPel MLR Backless Pathology Gown 1-Ply Front, 2-Ply sleeves, size Small
10634916797173Surgical GWN MLR CMPL 2-Ply Front/Sleeves Aqua Compel MLR and White Compel MLR w/Negastat, 1-Pl
10634916797166Surgical GWN MLR CMPL 2-Ply Front/Sleeves Aqua Compel MLR and White Compel MLR w/Negastat, 1-Pl
10634916797159Surgical GWN MLR CMPL 2-Ply Front/Sleeves Aqua Compel MLR and White Compel MLR w/Negastat, 1-Pl
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.