STANDARD TEXTILE CO., INC.

Address:1 Knollcrest Dr,Cincinnati,OH,45237,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Drape, Surgical (KKX) (8) Drape, Surgical, Exempt (PUI) (2)

Premarket Exempt

Yes No

Clear

Stanguard Drape - 00634916001082 Catalog Number : 22636022

Device Description : SM UNIV DRAPE StanGuard - 20X20 BARRIER SUPREME

Device Class :

Duns Number: 006999858

Premarket Exempt : Yes

Product Code : PUI

Prescription Use : No

Device Count : 72

StanGuard Drape - 00634916001099 Catalog Number : 22653122

Device Description : TABLE COVER StanGuard 58X79 - BARRIER SUPREME (SR 11910)

Device Class :

Duns Number: 006999858

Premarket Exempt : Yes

Product Code : PUI

Prescription Use : No

Device Count : 36

ComPel Surgical Drape - 00634916001167 Catalog Number : 27710042

Device Description : OVERHEAD TABLE COVER 1PLY - 100X100 WRAPPEL"T"/COMPEL XTR-

Device Class :

Duns Number: 006999858

Premarket Exempt : No

Product Code : KKX

Prescription Use : No

Device Count : 6

ComPel Surgical Drape - 00634916001174 Catalog Number : 27710812

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

Device Class :

Duns Number: 006999858

Premarket Exempt : No

Product Code : KKX

Prescription Use : No

Device Count : 12

ComPel XTR Mayo Cover - 00634916001181 Catalog Number : 27711702

Device Description : COMPEL XTR MAYO COVER XTR/W - 22X54 REIN 30"L

Device Class :

Duns Number: 006999858

Premarket Exempt : No

Product Code : KKX

Prescription Use : No

Device Count : 36

ComPel Surgical Drape - 00634916001198 Catalog Number : 27751502

Device Description : UNDER BUTTOCKS DRAPE BARTACKED - 28.25X47.25 1 PLY COMPEL

Device Class :

Duns Number: 006999858

Premarket Exempt : No

Product Code : KKX

Prescription Use : No

Device Count : 48

ComPel Surgical Drape - 00634916001204 Catalog Number : 27760472

Device Description : FLAP/SNAP WINGED LAP DRAPE - 108X130 WRAPPEL T/COMPL/ZORII

Device Class :

Duns Number: 006999858

Premarket Exempt : No

Product Code : KKX

Prescription Use : No

Device Count : 12

ComPel Surgical Drape - 00634916001211 Catalog Number : 27760492

Device Description : FLAP/SNAP WNGD LG FEN DR 1PLY - 108X130 WTPLT/CMPL/ZORWIK II

Device Class :

Duns Number: 006999858

Premarket Exempt : No

Product Code : KKX

Prescription Use : No

Device Count : 12

ComPel Surgical Drape - 00634916001228 Catalog Number : 27760712

Device Description : UNIVERSAL FOOT DRAPE QCM#3 - 70X70 WRAPPEL T/ZORWIK II

Device Class :

Duns Number: 006999858

Premarket Exempt : No

Product Code : KKX

Prescription Use : No

Device Count : 36

ComPel Surgical Drape - 00634916001235 Catalog Number : 27760812

Device Description : ComPel Surgical Drape BACK TABLE COVER QCM#3 - 60X90 WRAPPEL T/COMPEL

Device Class :

Duns Number: 006999858

Premarket Exempt : No

Product Code : KKX

Prescription Use : No

Device Count : 12

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