ComPel Mayo Cover 27751702

GUDID 00634916005585

COMPEL MAYO COVER - 22X54 W/QCM#3

STANDARD TEXTILE CO., INC.

General-purpose surgical drape, reusable, sterile
Primary Device ID00634916005585
NIH Device Record Key38e456c9-f7b9-4aab-b568-f7c4e44e8981
Commercial Distribution StatusIn Commercial Distribution
Brand NameComPel Mayo Cover
Version Model Number27751702
Catalog Number27751702
Company DUNS006999858
Company NameSTANDARD TEXTILE CO., INC.
Device Count72
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100634916005585 [Primary]
GS110634916005582 [Unit of Use]
GS110634916005585 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KKXDrape, Surgical

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00634916005585]

Moist Heat or Steam Sterilization

[00634916005585]

Moist Heat or Steam Sterilization

[00634916005585]

Moist Heat or Steam Sterilization

[00634916005585]

Moist Heat or Steam Sterilization

[00634916005585]

Moist Heat or Steam Sterilization

[00634916005585]

Moist Heat or Steam Sterilization

[00634916005585]

Moist Heat or Steam Sterilization

[00634916005585]

Moist Heat or Steam Sterilization

[00634916005585]

Moist Heat or Steam Sterilization

[00634916005585]

Moist Heat or Steam Sterilization

[00634916005585]

Moist Heat or Steam Sterilization

[00634916005585]

Moist Heat or Steam Sterilization

[00634916005585]

Moist Heat or Steam Sterilization

[00634916005585]

Moist Heat or Steam Sterilization

[00634916005585]

Moist Heat or Steam Sterilization

[00634916005585]

Moist Heat or Steam Sterilization

[00634916005585]

Moist Heat or Steam Sterilization

[00634916005585]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2018-01-29

Devices Manufactured by STANDARD TEXTILE CO., INC.

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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
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