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

Wrap, Sterilization (FRG) (7) Drape, Surgical, Exempt (PUI) (1) Gown, Examination (FME) (1) Gown, Surgical (FYA) (1)

Premarket Exempt

No Yes

Clear

Standard Supreme Drape - 00634916000016 Catalog Number : 95301682

Device Description : Bronch Cover, Standard Supreme T180, Twill Tape Ties at Top Opening, 1Ply Body, Bronch Cover, Standard Supreme T180, Twill Tape Ties at Top Opening, 1Ply Body, 2 Ply Front Pocket Panel, Misty, 21 3/4 x 44

Device Class :

Duns Number: 006999858

Premarket Exempt : Yes

Product Code : PUI

Prescription Use : No

Device Count : 24

MAMOGRAM CAPE - 00634916000108 Catalog Number : 74343099

Device Description : MAMOGRAM CAPE, Lilac OSFA, Front Opening w/metal snaps

Device Class :

Duns Number: 006999858

Premarket Exempt : Yes

Product Code : FME

Prescription Use : No

Device Count : 24

COMPEL SURGICAL GOWN - 00634916000337 Catalog Number : 75613355

Device Description : Surgical Gown ComPel, Beryl Green, L, 2Ply FRT/Slv-l NK-TIE NK/WST

Device Class :

Duns Number: 006999858

Premarket Exempt : No

Product Code : FYA

Prescription Use : No

Device Count : 24

Standard Supreme Wrapper - 00634916000573 Catalog Number : 21521502

Device Description : WRAPPER 18X18 MISTY STANDARD SUPREME - 18X18 MERROWED W/LAVENDER THRD

Device Class :

Duns Number: 006999858

Premarket Exempt : No

Product Code : FRG

Prescription Use : No

Device Count : 144

Standard Supreme Wrapper - 00634916000580 Catalog Number : 21522002

Device Description : WRAPPER STANDARD SUPREME MTY 23X23 2PLY - MERROWED W/GREEN THREAD

Device Class :

Duns Number: 006999858

Premarket Exempt : No

Product Code : FRG

Prescription Use : No

Device Count : 144

Standard Supreme Wrapper - 00634916000597 Catalog Number : 21522802

Device Description : WRAPPER STANDARD SUPREME MTY 30X30 2PLY - MERROWED W/PINK THREAD

Device Class :

Duns Number: 006999858

Premarket Exempt : No

Product Code : FRG

Prescription Use : No

Device Count : 72

Standard Supreme Wrapper - 00634916000603 Catalog Number : 21523002

Device Description : WRAPPER STANDARD SUPREME MTY 35X35 2PLY - MERROWED W/BLUE THREAD

Device Class :

Duns Number: 006999858

Premarket Exempt : No

Product Code : FRG

Prescription Use : No

Device Count : 72

Standard Supreme Wrapper - 00634916000610 Catalog Number : 21525002

Device Description : WRAPPER STANDARD SUPREME MTY 45X45 2PLY - MERROWED W/WHITE THREAD

Device Class :

Duns Number: 006999858

Premarket Exempt : No

Product Code : FRG

Prescription Use : No

Device Count : 72

Standard Supreme Wrapper - 00634916000627 Catalog Number : 21526002

Device Description : WRAPPER STANDARD SUPREME MTY 54X54 2PLY - MERROWED W/BLUE THREAD

Device Class :

Duns Number: 006999858

Premarket Exempt : No

Product Code : FRG

Prescription Use : No

Device Count : 36

Standard Supreme Wrapper (hemmed) - 00634916000634 Catalog Number : 21526012

Device Description : WRAPPER T-180 MTY 54X54 2PLY - HEMMED W/GREY THREAD

Device Class :

Duns Number: 006999858

Premarket Exempt : No

Product Code : FRG

Prescription Use : No

Device Count : 60

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