Side Drape

GUDID 10634916809401

Side Drape, 100% Polyester, Wrappel Body, Zorwik / Compel Pad, SIZE 36x72

STANDARD TEXTILE CO., INC.

Patient surgical drape, reusable
Primary Device ID10634916809401
NIH Device Record Key3962a9e3-f561-4a68-9dd2-8522c7d7cedb
Commercial Distribution StatusIn Commercial Distribution
Brand NameSide Drape
Version Model Number95901855
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
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
GS100634916809404 [Primary]
GS110634916809401 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KKKSudan Iv
KKXDrape, Surgical

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10634916809401]

Moist Heat or Steam Sterilization


[10634916809401]

Moist Heat or Steam Sterilization


[10634916809401]

Moist Heat or Steam Sterilization


[10634916809401]

Moist Heat or Steam Sterilization


[10634916809401]

Moist Heat or Steam Sterilization


[10634916809401]

Moist Heat or Steam Sterilization


[10634916809401]

Moist Heat or Steam Sterilization


[10634916809401]

Moist Heat or Steam Sterilization


[10634916809401]

Moist Heat or Steam Sterilization


[10634916809401]

Moist Heat or Steam Sterilization


[10634916809401]

Moist Heat or Steam Sterilization


[10634916809401]

Moist Heat or Steam Sterilization


[10634916809401]

Moist Heat or Steam Sterilization


[10634916809401]

Moist Heat or Steam Sterilization


[10634916809401]

Moist Heat or Steam Sterilization


[10634916809401]

Moist Heat or Steam Sterilization


[10634916809401]

Moist Heat or Steam Sterilization


[10634916809401]

Moist Heat or Steam Sterilization


[10634916809401]

Moist Heat or Steam Sterilization


[10634916809401]

Moist Heat or Steam Sterilization


[10634916809401]

Moist Heat or Steam Sterilization


[10634916809401]

Moist Heat or Steam Sterilization


[10634916809401]

Moist Heat or Steam Sterilization


[10634916809401]

Moist Heat or Steam Sterilization


[10634916809401]

Moist Heat or Steam Sterilization


[10634916809401]

Moist Heat or Steam Sterilization


[10634916809401]

Moist Heat or Steam Sterilization


[10634916809401]

Moist Heat or Steam Sterilization


[10634916809401]

Moist Heat or Steam Sterilization


[10634916809401]

Moist Heat or Steam Sterilization


[10634916809401]

Moist Heat or Steam Sterilization


[10634916809401]

Moist Heat or Steam Sterilization


[10634916809401]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-06-21
Device Publish Date2021-06-11

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

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