ComPel OR Gown

GUDID 00634916788358

2-Ply Front/Sleeves Aqua Compel MLR and White ComPel MLR with Negastat, 1-Ply Aqua MLR Comfort Panel Backs, Snap Closures at Neck, Tie Closures at Waist, Circumferentially Offset Sleeves, Overcast Safety Stitch Body

STANDARD TEXTILE CO., INC.

Surgical gown, reusable
Primary Device ID00634916788358
NIH Device Record Keye588475f-c1c2-42de-af58-71509190be02
Commercial Distribution StatusIn Commercial Distribution
Brand NameComPel OR Gown
Version Model Number75647454
Company DUNS006999858
Company NameSTANDARD TEXTILE CO., INC.
Device Count1
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 Latextrue
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
GS100634916788358 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FYAGown, Surgical

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00634916788358]

Moist Heat or Steam Sterilization

[00634916788358]

Moist Heat or Steam Sterilization

[00634916788358]

Moist Heat or Steam Sterilization

[00634916788358]

Moist Heat or Steam Sterilization

[00634916788358]

Moist Heat or Steam Sterilization

[00634916788358]

Moist Heat or Steam Sterilization

[00634916788358]

Moist Heat or Steam Sterilization

[00634916788358]

Moist Heat or Steam Sterilization

[00634916788358]

Moist Heat or Steam Sterilization

[00634916788358]

Moist Heat or Steam Sterilization

[00634916788358]

Moist Heat or Steam Sterilization

[00634916788358]

Moist Heat or Steam Sterilization

[00634916788358]

Moist Heat or Steam Sterilization

[00634916788358]

Moist Heat or Steam Sterilization

[00634916788358]

Moist Heat or Steam Sterilization

[00634916788358]

Moist Heat or Steam Sterilization

[00634916788358]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-10-18
Device Publish Date2023-10-10

Devices Manufactured by STANDARD TEXTILE CO., INC.

00634916019353 - Standard Supreme2026-03-19 Instrument Drape, 2 Ply Standard Supreme, 5% COTTON, 45% POLYESTER
00634916099225 - INSTRUMENT COVER2026-03-19 Instrument Cover, 2 Ply T-180, 55% Cotton, 45% Polyester
00634916120905 - Instrument Holder2026-03-19 Wrappel Instrument Holder with Pockets, 100% Polyester
00634916349740 - Compel MLR OR Gown2026-03-19 Compel MLR OR Gown, Snap Closures at Neck, 100% POLYESTER.
00634916781373 - WrapPel Table Cover2026-03-19 WrapPel Table Cover with Pad (1 Ply), 100% POLYESTER'
00634916788105 - Compel MLR OR Gown2026-03-19 Compel MLR OR Gown 2-Ply Front/Sleeves, Tie, 100% POLYESTER.
00634916788112 - Compel MLR OR Gown2026-03-19 Compel MLR OR Gown 2-Ply Front/Sleeves, Tie, 100% POLYESTER.
00634916788129 - Compel MLR OR Gown2026-03-19 Compel MLR OR Gown, 2-Ply Front/Sleeves, Tie 100% POLYESTER
© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.