Barrier Supreme Surgical Drape 95689202

GUDID 00634916014921

DRAPE ENDO/CYSTO Barrier Supreme 45X75 - 4.5 RND FEN SR9753 PRO# 770.0

STANDARD TEXTILE CO., INC.

General-purpose surgical drape, reusable, sterile
Primary Device ID00634916014921
NIH Device Record Key6828d09f-34c9-4c5d-a1dc-d47d6c865328
Commercial Distribution StatusIn Commercial Distribution
Brand NameBarrier Supreme Surgical Drape
Version Model Number95689202
Catalog Number95689202
Company DUNS006999858
Company NameSTANDARD TEXTILE CO., INC.
Device Count12
DM Exemptfalse
Pre-market Exempttrue
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
Phone1-800-999-0400
EmailGUDID@standardtextile.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100634916014921 [Primary]
GS110634916014921 [Unit of Use]
GS110634916014928 [Unit of Use]

FDA Product Code

PUIDrape, Surgical, Exempt

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00634916014921]

Moist Heat or Steam Sterilization


[00634916014921]

Moist Heat or Steam Sterilization


[00634916014921]

Moist Heat or Steam Sterilization


[00634916014921]

Moist Heat or Steam Sterilization


[00634916014921]

Moist Heat or Steam Sterilization


[00634916014921]

Moist Heat or Steam Sterilization


[00634916014921]

Moist Heat or Steam Sterilization


[00634916014921]

Moist Heat or Steam Sterilization


[00634916014921]

Moist Heat or Steam Sterilization


[00634916014921]

Moist Heat or Steam Sterilization


[00634916014921]

Moist Heat or Steam Sterilization


[00634916014921]

Moist Heat or Steam Sterilization


[00634916014921]

Moist Heat or Steam Sterilization


[00634916014921]

Moist Heat or Steam Sterilization


[00634916014921]

Moist Heat or Steam Sterilization


[00634916014921]

Moist Heat or Steam Sterilization


[00634916014921]

Moist Heat or Steam Sterilization


[00634916014921]

Moist Heat or Steam Sterilization


[00634916014921]

Moist Heat or Steam Sterilization


[00634916014921]

Moist Heat or Steam Sterilization


[00634916014921]

Moist Heat or Steam Sterilization


[00634916014921]

Moist Heat or Steam Sterilization


[00634916014921]

Moist Heat or Steam Sterilization


[00634916014921]

Moist Heat or Steam Sterilization


[00634916014921]

Moist Heat or Steam Sterilization


[00634916014921]

Moist Heat or Steam Sterilization


[00634916014921]

Moist Heat or Steam Sterilization


[00634916014921]

Moist Heat or Steam Sterilization


[00634916014921]

Moist Heat or Steam Sterilization


[00634916014921]

Moist Heat or Steam Sterilization


[00634916014921]

Moist Heat or Steam Sterilization


[00634916014921]

Moist Heat or Steam Sterilization


[00634916014921]

Moist Heat or Steam Sterilization


[00634916014921]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2018-01-29

On-Brand Devices [Barrier Supreme Surgical Drape]

00634916327731DRP UNIV HEART 24X24 MISTY - 1PLY BARRIER SUPREME 7.75"FEN SR18816B
00634916225389DRAPE SURGICAL 15.5x15.5 CEIL - 2PLY Barrier Supreme 6X5 FEN SR16837
00634916197440CIRCUMCISION DRAPE 14X15 MISTY - 2PLY Barrier Supreme W/1"FEN SR16685
00634916190564EYE DRAPE 26X36.5 MISTY - 3"FEN Standard/Barrier Supreme (SR 16571)
00634916187038DRAPE SM UNIV Barrier Supreme JADE 25.5x19 - W/9X11 REINF FEN (S/R 16419)
00634916183016LAP Drape Barrier Supreme CEIL 84X69 - WINGED 1PLY 5X20 FEN (SR16384)
00634916171396Small Universal Fenestrated Drape, 1-Ply Barrier Supreme, KAUM 20X20 - RM (98 8155) USE: 2262602
00634916147018LEGGING Barrier Supreme 15.25X35.5 - 1PLY (SR 16132) MISTY
00634916127355DRAPE LAP Barrier Supreme CEIL 98X120 - W/5X17 OVAL FEN (SR 15512)
00634916098099DRAPE LAP BARRIER SUPREME CEIL 83.5X108.25 - W/5X17 OVAL FEN
00634916087895DRAPE TOP HEART Barrier Supreme CEIL - 73X85.5 W/U-FEN (SR 14271)
00634916087888DRP BTTM HEART Barrier Supreme CEIL - 73X83 W/U-FEN (SR 14272)
00634916043105MAYO COVER T180/BS 24X48 MISTY - 1PLY (S/R 11942)
00634916043099CIRCUMCISION SHEET 25X25 JADE - 1PLY T180/BARRIER SUPREME (S/R 11943)
00634916043082DRP CYSTO T180/Barrier Supreme JADE 66X56 - 4.5 RND FEN (S/R 11944)
00634916042023WINDOW DRAPE BARRIER SUPREME JADE - 26X20 W/FEN (S/R 11908)
00634916033083SM UNIV DRAPE CEIL 20X20 - BARRIER SUPREME (S/R 11536)
00634916031263DRAPE CORONARY BPASS CBL 106X120 - T180 Barrier Supreme 12X50 FEN (SR 11405
00634916016888Drape Sheet Barrier Supreme MTY 45X90 - (S/R 10053) PRO# 788.0
00634916014921DRAPE ENDO/CYSTO Barrier Supreme 45X75 - 4.5 RND FEN SR9753 PRO# 770.0
00634916008272TREATMENT DRAPE SPECIAL - 45X45 1 PLY Barrier Supreme BLUE
00634916008258Drape Sheet Barrier Supreme 44x85 - 1PLY QCM/MRKM LABEL (SR 11827)
00634916005431CIRCUMCISION DRAPES SPECIAL - 22X22 1PLY BARRIER SUPREME
00634916708578Barrier Supreme Surgical Drape, 1 -Ply T180 Base, 1 Ply 6 3/4" x 7" Barrier Supreme Reinforcemen

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