Promax Mayo Cover 95869705

GUDID 00634916047875

MAYO COVER PROMAX/WRAPPEL 22X54 - (S/R 12185)

STANDARD TEXTILE CO., INC.

General-purpose surgical drape, reusable, sterile
Primary Device ID00634916047875
NIH Device Record Key3596f806-0c5f-4c49-9c07-25da513f99f1
Commercial Distribution StatusIn Commercial Distribution
Brand NamePromax Mayo Cover
Version Model Number95869705
Catalog Number95869705
Company DUNS006999858
Company NameSTANDARD TEXTILE CO., INC.
Device Count36
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
GS100634916047875 [Primary]
GS110634916047875 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KKXDrape, Surgical

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00634916047875]

Moist Heat or Steam Sterilization

[00634916047875]

Moist Heat or Steam Sterilization

[00634916047875]

Moist Heat or Steam Sterilization

[00634916047875]

Moist Heat or Steam Sterilization

[00634916047875]

Moist Heat or Steam Sterilization

[00634916047875]

Moist Heat or Steam Sterilization

[00634916047875]

Moist Heat or Steam Sterilization

[00634916047875]

Moist Heat or Steam Sterilization

[00634916047875]

Moist Heat or Steam Sterilization

[00634916047875]

Moist Heat or Steam Sterilization

[00634916047875]

Moist Heat or Steam Sterilization

[00634916047875]

Moist Heat or Steam Sterilization

[00634916047875]

Moist Heat or Steam Sterilization

[00634916047875]

Moist Heat or Steam Sterilization

[00634916047875]

Moist Heat or Steam Sterilization

[00634916047875]

Moist Heat or Steam Sterilization

[00634916047875]

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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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
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