ComPel Surgical Drape 27710812

GUDID 00634916001174

BACK TABLE COVER XTR CNTR PAD - 1PLY60X90 WRAP/1PLY COMPEL/XTR

STANDARD TEXTILE CO., INC.

General-purpose surgical drape, reusable, sterile
Primary Device ID00634916001174
NIH Device Record Key9542c183-2f2a-414d-988a-4373ef2cef71
Commercial Distribution StatusIn Commercial Distribution
Brand NameComPel Surgical Drape
Version Model Number27710812
Catalog Number27710812
Company DUNS006999858
Company NameSTANDARD TEXTILE CO., INC.
Device Count12
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100634916001174 [Primary]
GS110634916001171 [Unit of Use]
GS110634916001174 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KKXDrape, Surgical

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00634916001174]

Moist Heat or Steam Sterilization

[00634916001174]

Moist Heat or Steam Sterilization

[00634916001174]

Moist Heat or Steam Sterilization

[00634916001174]

Moist Heat or Steam Sterilization

[00634916001174]

Moist Heat or Steam Sterilization

[00634916001174]

Moist Heat or Steam Sterilization

[00634916001174]

Moist Heat or Steam Sterilization

[00634916001174]

Moist Heat or Steam Sterilization

[00634916001174]

Moist Heat or Steam Sterilization

[00634916001174]

Moist Heat or Steam Sterilization

[00634916001174]

Moist Heat or Steam Sterilization

[00634916001174]

Moist Heat or Steam Sterilization

[00634916001174]

Moist Heat or Steam Sterilization

[00634916001174]

Moist Heat or Steam Sterilization

[00634916001174]

Moist Heat or Steam Sterilization

[00634916001174]

Moist Heat or Steam Sterilization

[00634916001174]

Moist Heat or Steam Sterilization

[00634916001174]

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

On-Brand Devices [ComPel Surgical Drape]

00634916343182WINGED TRANSVERSE LAP QCM#3 - 108X133 WRAPPEL "T"/COMPEL/ZOR
00634916303940DRAPE GYNECOLOGICAL 70.5X77 - WRAPPEL/CMPL/ZORWICK (SR17846)
00634916284324BACK TABLE BARR COVER 65X59 - WRPPL/CMPL/ZRWK GREEN SR17227
00634916284300DRAPE GYNECOLOGICAL 71X71 GRN - WRAPPEL/CMPL/ZORWICK (SR17216)
00634916284294MAYO STAND BARR COVER 34.5X55 - WRPPL/CMPL/ZRWCK GREEN SR17226
00634916284263DRAPE LARGE BARRIER 71X71 GRN - WRAPPEL/COMPEL/ZORWICK (SR17212)
00634916284256DRAPE MEDIUM BARRIER 55X71 GRN - WRAPPEL/COMPEL/ZORWICK (SR17211)
00634916276442DOUBLE SPLIT DRAPE 80X106 BLUE - WRAPPEL/XTR/ZORWICK (SR 17474)
00634916263794C-ARM COVER WRAPPEL 46X136 BLU - 2PLY WRAPPEL BLUE (SR 16159)
00634916243260SMALL UNIV DRAPE KAUM 20X20 QCM#3 - RM (98 8155) USE: 27761602
00634916232394DRAPE HEART WRPPL 95X95 BLUE - W/POCKETS & FLAP (SR 16272)
00634916188233RECTANGULAR LEGGING 1 PLY KAUM - RM (98 8131) USE: 27761402
00634916188103LG DRAPE SHEET WRAPPEL T KAUM - RM (98 8131) USE: 27764152
00634916181029SHEET X-LARGE WRAPPEL T 72X104 - 1PLY BARCODE, RFID CHIP
00634916146035COMPEL XTR MAYO COVER XTR/Z/W - 27X60 AQUA BINDING (SR 16062)
00634916143379COMPEL XTR MAYO COVER XTR/WRPL - 27x54 WHITE BINDING 100% POLY
00634916143362MAYO CVR CMPL XTR/WRPPL 25X54 - W/BARCODE & RFID (SR 15979)
00634916142488DRAPE INCISION 30X30 BLUE - WRAPPEL/COMPEL/ZORWIK II (SR 15985)
00634916141849MAYO COVER COMPEL XTR 22X54 - 2PLY WRRPL/1PLY XTR W/BARCODE
00634916141832BACK TABLE COVER CTR PAD 60X90 - WRPPL/CMPL/XTR W/BARCODE
00634916128598LITHOTOMY DRAPE W/Z/C 68X86 - 16X20 PAD 3X6 FEN (SR 15566)
00634916109825DRAPE CENTRAL LINE 70.25X118.5 - COMPEL/WRAPPEL/ZORWICK W/11X20 FEN (S/R 14915)
00634916104172ARM BOARD COVER 15.50X27 BLUE - 1PLY WRAPPEL (SR 14877)
00634916101751HALF DRAPE SHEET WRAPPEL T KAUM 46X72 BLU - RM (98 7733) USE: 27764182
00634916101744LG DRAPE SHEET WRAPPEL T KAUM 90X60 - RM (98 7733) USE: 27764152
00634916101737MEDIUM DRAPE SHEET WRAPPEL T KAUM 62X72 - RM (98 7733) USE: 27764172
00634916098747MAYO CVR CMPL XTR/WRPPL 22X54 - (S/R 14715)
00634916098730MEDIUM DRAPE SHT WRAPPEL 62X72 - 1PLY MERROWED (S/R 14715)
00634916098716BACK TABLE COVER XTR 60X90 - WRAP/COMPEL/XTR (S/R 14715)
00634916084160DRAPE EAR BLUE 70X108 - WRPPL/CMPL/ZRWK (SR 13901)
00634916080032SM UNIV DRP CMP QC3 20X20 KAUM - RM (98 7647) USE: 27761602
00634916079999HALF DRAPE SHEET WRAPPEL T 46X72 KAUM - RM(98 7647)2-KAUM'USE:27764182
00634916079463DRAPE SURGICAL BLUE 33X33 - WRPPL/CMPL/ZRWK (SR 13694)
00634916076257CARDIAC MAYO CVR 60.25X61.75 - WRAPPEL 1PLY (S/R 13598)
00634916057959MEDIUM DRAPE SHEET WRAPPEL T - 62X72 1PLY (NAFTA)
00634916055801LEG DRAPE WRAPPEL 33X50.5 BLUE - W/PKT MICROFIBRE HLS #2199
00634916055795ARM DRAPE WRAPPEL 25.25X30.5 BLUE - W/PKT MICROFIBRE HLS #2197
00634916053104DRAPE THORACIC 113X133 BLUE - CMPL/WRPPL/ZRWK (SR 12587)
00634916048315PEDIATRIC LAP DRAPE 34X60 - WRAPPEL/CMPL/ZORW (S/R 12422)
00634916041972Utility Drape, 27x36 BLUE, 1-Ply Wrappel, 1-Ply 12x26 XTR Pad, - BARCODE 95-9026 (SR 11809)
00634916041965LAP DRAPE C/W/Z 71X131 CEIL - W/10X7 FEN (S/R 11892)
00634916034189PHELAN DRAPE BLUE 100X152 - W/BARCODE XTR SPLIT (SR 11662)
00634916033281RECTANGULAR LEGGING 1 PLY - 30X50 WRAPPEL T W/WHITE BIN
00634916033267COMPEL XTR UNDR EXTREMITY DRAPE - 70X70 WR/XTR QCM RED TO HEAD
00634916033250X-LARGE DRAPE SHEET WRAPPEL T 104X72 - 1PLY
00634916033212LUMP & BUMP DRP C/W/ZII 44X58 - FEN 6X6 SQ W/RND CRNRS
00634916033205UNIVERSAL BAR DRAPE 106X70 - W/C/ZII X-LONG LENGTH
006349160331993/4 DRAPE SHEET WRAPPEL T 80X60 - 1PLY
00634916032857F&S UNIVERSAL SIDE DRAPE 45X80 - WRPL"T"/ZRWKII W/SNAP&FLAP
00634916032840FLAP/SNAP WNGD LAP/LITHO DRAPE - 100X108 1PLY WRAPPEL"T"/COMPEL
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