Fenestrated Surgical Drape 96301553

GUDID 00634916307825

DRAPE MULTI PURPOSE 13X17 JADE - T180 ATCHD PAD 5"FEN (SR17814)

STANDARD TEXTILE CO., INC.

General-purpose surgical drape, reusable, sterile
Primary Device ID00634916307825
NIH Device Record Key619f490c-efcf-4a3a-abbe-ad56d2bc9656
Commercial Distribution StatusIn Commercial Distribution
Brand NameFenestrated Surgical Drape
Version Model Number96301553
Catalog Number96301553
Company DUNS006999858
Company NameSTANDARD TEXTILE CO., INC.
Device Count72
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100634916307825 [Primary]
GS110634916307822 [Unit of Use]
GS110634916307825 [Unit of Use]

FDA Product Code

PUIDrape, Surgical, Exempt

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00634916307825]

Moist Heat or Steam Sterilization


[00634916307825]

Moist Heat or Steam Sterilization


[00634916307825]

Moist Heat or Steam Sterilization


[00634916307825]

Moist Heat or Steam Sterilization


[00634916307825]

Moist Heat or Steam Sterilization


[00634916307825]

Moist Heat or Steam Sterilization


[00634916307825]

Moist Heat or Steam Sterilization


[00634916307825]

Moist Heat or Steam Sterilization


[00634916307825]

Moist Heat or Steam Sterilization


[00634916307825]

Moist Heat or Steam Sterilization


[00634916307825]

Moist Heat or Steam Sterilization


[00634916307825]

Moist Heat or Steam Sterilization


[00634916307825]

Moist Heat or Steam Sterilization


[00634916307825]

Moist Heat or Steam Sterilization


[00634916307825]

Moist Heat or Steam Sterilization


[00634916307825]

Moist Heat or Steam Sterilization


[00634916307825]

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 [Fenestrated Surgical Drape]

00634916349504Heart Drape, 30 x 34, 1-Ply, Perval Bleach, 10 3/4 x 6 1/2 Rectangular Fenestration, Binding Ar
00634916307832DRAPE MULTI PURPOSE 13X17 CEIL - T180 ATCHD PAD 3"FEN (SR17813)
00634916307825DRAPE MULTI PURPOSE 13X17 JADE - T180 ATCHD PAD 5"FEN (SR17814)
00634916247039DRAPE SURGICAL MISTY 18X18 - 2PLY T-180 W/FEN (S/R 17103)
00634916232387DRAPE T180 25X25 CEIL BLUE - W/5" SQUARE FEN (S/R 16988)
00634916232141DRAPE CIRCUMCISION 17X13 CEIL - W/1" ROUND FEN (S/R 16900)
00634916186925DRAPE CIRCUMCISION 18X24 BLEA - 1PLY T180 W/FEN (SR 14998)
00634916028218DRAPE CIRCUMCISION CEIL 17X17 - W/3/4" RND FEN (S/R 11101)

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