Standard Supreme Drape 95301592

GUDID 00634916322552

HEART POCKET T180 12X15.5 MSTY - 1PLY STANDARD SUPREME W/TABS (SR18824)

STANDARD TEXTILE CO., INC.

General-purpose surgical drape, reusable, sterile
Primary Device ID00634916322552
NIH Device Record Key54797d77-c1e2-472c-b983-c38dd604847c
Commercial Distribution StatusIn Commercial Distribution
Brand NameStandard Supreme Drape
Version Model Number95301592
Catalog Number95301592
Company DUNS006999858
Company NameSTANDARD TEXTILE CO., INC.
Device Count144
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
GS100634916322552 [Primary]
GS110634916322552 [Unit of Use]

FDA Product Code

PUIDrape, Surgical, Exempt

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00634916322552]

Moist Heat or Steam Sterilization


[00634916322552]

Moist Heat or Steam Sterilization


[00634916322552]

Moist Heat or Steam Sterilization


[00634916322552]

Moist Heat or Steam Sterilization


[00634916322552]

Moist Heat or Steam Sterilization


[00634916322552]

Moist Heat or Steam Sterilization


[00634916322552]

Moist Heat or Steam Sterilization


[00634916322552]

Moist Heat or Steam Sterilization


[00634916322552]

Moist Heat or Steam Sterilization


[00634916322552]

Moist Heat or Steam Sterilization


[00634916322552]

Moist Heat or Steam Sterilization


[00634916322552]

Moist Heat or Steam Sterilization


[00634916322552]

Moist Heat or Steam Sterilization


[00634916322552]

Moist Heat or Steam Sterilization


[00634916322552]

Moist Heat or Steam Sterilization


[00634916322552]

Moist Heat or Steam Sterilization


[00634916322552]

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 Drape]

00634916343168DRAPE SHT Standard Supreme MISTY 35X90 - 1PLY 50/50 T-180
00634916322552HEART POCKET T180 12X15.5 MSTY - 1PLY STANDARD SUPREME W/TABS (SR18824)
00634916256970SHT OPEN HEART 25X66 MISTY - 2PLY STD SUPREME (SR 17334)
00634916091052SPINAL DRAPE SHEET STANDARD SUPREME MISTY 28X32 - 2PLY STD SUP W/3X3 BND FEN
00634916045383SPINAL DRAPE SHEET 29X29 JADE SPECIAL - 29X29 1 PLY STD SUP (SR 12196)
00634916018141ARM SHEETS STANDARD SUPREME 31X60 MISTY - 31X60 2PLY
00634916018134Standard Supreme RECTANG LEGGING T-180 JADE - 12X36 T-180 SINGLE PLY
00634916012422DRAPE EYE 30X30 JADE - 2PLY STANDARD SUPREMEW/FEN PRO#723.0
00634916010374GOITER SHEET MISTY 72X90 - 1 PLY STD SUPREME HEMMED
00634916007770EYE DRAPE 18X18 MISTY - 1PLY STANDARD SUPREME W/REIN (S/R 12161)
00634916005363SPINAL SHEET W/QCM 3 SPECIAL - 34X34 1PLY STD SUP W/REIN CO
00634916005356PERI SHEET STD SUPREME 49X70 - 1PLY STD S W/REIN-CO
00634916000016Bronch Cover, Standard Supreme T180, Twill Tape Ties at Top Opening, 1 Ply Body, 2 Ply Front Poc

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.