Standard Supreme Surgical Drape 95512534

GUDID 00634916005394

BOOT LEGGING CEIL - 1PLY STANDARD SUPREME (SR 15224)

STANDARD TEXTILE CO., INC.

General-purpose surgical drape, reusable, sterile
Primary Device ID00634916005394
NIH Device Record Key494d77cc-b48d-4377-bf43-16eb1a4df39b
Commercial Distribution StatusIn Commercial Distribution
Brand NameStandard Supreme Surgical Drape
Version Model Number95512534
Catalog Number95512534
Company DUNS006999858
Company NameSTANDARD TEXTILE CO., INC.
Device Count36
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100634916005394 [Primary]
GS110634916005391 [Unit of Use]
GS110634916005394 [Unit of Use]

FDA Product Code

PUIDrape, Surgical, Exempt

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00634916005394]

Moist Heat or Steam Sterilization

[00634916005394]

Moist Heat or Steam Sterilization

[00634916005394]

Moist Heat or Steam Sterilization

[00634916005394]

Moist Heat or Steam Sterilization

[00634916005394]

Moist Heat or Steam Sterilization

[00634916005394]

Moist Heat or Steam Sterilization

[00634916005394]

Moist Heat or Steam Sterilization

[00634916005394]

Moist Heat or Steam Sterilization

[00634916005394]

Moist Heat or Steam Sterilization

[00634916005394]

Moist Heat or Steam Sterilization

[00634916005394]

Moist Heat or Steam Sterilization

[00634916005394]

Moist Heat or Steam Sterilization

[00634916005394]

Moist Heat or Steam Sterilization

[00634916005394]

Moist Heat or Steam Sterilization

[00634916005394]

Moist Heat or Steam Sterilization

[00634916005394]

Moist Heat or Steam Sterilization

[00634916005394]

Moist Heat or Steam Sterilization

[00634916005394]

Moist Heat or Steam Sterilization

[00634916005394]

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 [Standard Supreme Surgical Drape]

00634916322569CIRCUMCISION DRAPE 22X22 MISTY - 2PLY Standard Supreme 2.5"FEN (SR18823)
00634916309812CIRCUMCISION DRAPE 12X12 JADE - 2PLY 3/4"FEN SR17847
00634916263268BOOT LEGGING STANDARD SUPREME KAUM CEIL - RM (98 7802) USE: 95512534
00634916247084CIRCUMCISION DRAPE 23X23 MISTY - 1PLY Standard Supreme 1"FEN (SR17188)
00634916243185DRAPE UNIVERSAL JADE 22X22 - 2PLY Standard Supreme W/1"FEN S/R 14826
00634916230529DRAPE SPINAL CEIL 20X20 - 1PLY Standard Supreme 4"RND FEN SR16990
00634916230512Standard Supreme Spinal Surgical Drape SPINAL CEIL 33X33 - 1PLY 3"RND FEN SR16989
00634916191271CIRCUMCISION DRAPE 14.5X18 MTY - 1PLY Standard Supreme 1-3/8"FEN SR16585
00634916190779DRAPE SURGICAL 14X25 MISTY - 1PLY Standard Supreme W/3"FEN (SR16584)
00634916128727LEG WRAP Standard Supreme Surgical Drape T180 MISTY 6X112.75 - 2PLY HEMMED ALL SIDES SR15563
00634916105896DRAPE PED CHEST LAP CEIL - 79X94.5X54 STANDARD SUPREME (S/R 14884)
00634916102918DRAPE SHEET Standard Supreme MISTY - 70x106 2PLY
00634916080964DRAPE SURG MISTY 20.75X20.75 - 2PLY STANDARD SUPREME (SR 13813)
00634916080216DRAPE BUNNY CEIL 14.5X31.5 - 2PLY STANDARD SUPREME (SR 13835)
00634916064858DRAPE SUTURE Standard Supreme CEIL 22X22 - W/3" RND FEN (SR 12966)
00634916064841DRAPE SUTURE Standard Supreme CEIL 22X22 - W/2" RND FEN (SR 12965)
00634916063608DRAPE SUTURE Standard Supreme CEIL 22X22 - W/1" RND FEN (SR 12964)
00634916058147T-DRAPE STANDARD SUPREME JADE 12X12 - 4"SLIT W/1-1/2" FEN (SR 13078)
00634916029116DRAPE UNIVERSAL JADE 21X21.5 - 1PLY STANDARD SUPREME (S/R 11266)
00634916026696DRAPE CIRCUMCISION MISTY 12X12 - STANDARD SUPREME W/3/4" FEN (S/R 11062)
00634916023718DRAPE ANIMAL RESEARCH 48X72 MSTY - HEMMED ON 3 SIDES Standard Supreme (SR 10686)
00634916023688DRAPE DERM 1PLY 20X20 CEIL BL - W/1 PLY & 4"FENESTRATED CTRD(SR 10688)
00634916009378CIRCUMCISION DRAPE SPECIAL - 27X27 1PLY ST SUPREME MISTY
00634916005967SURGICAL DRAPE SPEC MISTY CUT - 18X36 1PLY Standard Supreme W/REIN/FEN
00634916005394BOOT LEGGING CEIL - 1PLY STANDARD SUPREME (SR 15224)
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