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) Wrap, Sterilization (FRG) (2)

Premarket Exempt

Yes No

Clear

ComPel Surgical Drape - 00634916001242 Catalog Number : 27761202

Device Description : ABDOMINAL DRAPE W/QCM#3 - 45X45 WRAPPEL T/ZORWIK II

Device Class :

Duns Number: 006999858

Premarket Exempt : No

Product Code : KKX

Prescription Use : No

Device Count : 36

ComPel Surgical Drape - 00634916001259 Catalog Number : 27761402

Device Description : RECTANGULAR LEGGING 1 PLY - 30X50 WRAPPEL T W/WHITE BIN

Device Class :

Duns Number: 006999858

Premarket Exempt : No

Product Code : KKX

Prescription Use : No

Device Count : 36

ComPel Surgical Drape - 00634916001266 Catalog Number : 27764032

Device Description : FLAP/SNAP WINGED LAP/LITHO DRAPE - 100X108 1PLY WRAPPEL T/COMPEL

Device Class :

Duns Number: 006999858

Premarket Exempt : No

Product Code : KKX

Prescription Use : No

Device Count : 6

ComPel Surgical Drape - 00634916001273 Catalog Number : 27764072

Device Description : FLAP & SNAP U DRAPE - 68X109 1PLY WRAPPELT /COMPEL/

Device Class :

Duns Number: 006999858

Premarket Exempt : No

Product Code : KKX

Prescription Use : No

Device Count : 6

ComPel Surgical Drape - 00634916001280 Catalog Number : 27764142

Device Description : X-LARGE SHEET WRAPPEL T - 104X72 1PLY

Device Class :

Duns Number: 006999858

Premarket Exempt : No

Product Code : KKX

Prescription Use : No

Device Count : 12

ComPel Surgical Drape - 00634916001297 Catalog Number : 27764152

Device Description : LG SHEET WRAPPEL T - 90X60 1 PLY

Device Class :

Duns Number: 006999858

Premarket Exempt : No

Product Code : KKX

Prescription Use : No

Device Count : 36

ComPel Surgical Drape - 00634916001303 Catalog Number : 27764172

Device Description : MEDIUM DRAPE SHEET WRAPPEL T - 62X72 1PLY

Device Class :

Duns Number: 006999858

Premarket Exempt : No

Product Code : KKX

Prescription Use : No

Device Count : 36

ComPel Surgical Drape - 00634916001310 Catalog Number : 27764182

Device Description : HALF DRAPE SHEET WRAPPEL T 46X72 BLUE - 1PLY

Device Class :

Duns Number: 006999858

Premarket Exempt : No

Product Code : KKX

Prescription Use : No

Device Count : 36

WrapPel Wrapper - 00634916001327 Catalog Number : 27766052

Device Description : STERILE WRAP WRAPPEL 12X12 1PL - 12X12 MERROWED-CC BLUE THR

Device Class :

Duns Number: 006999858

Premarket Exempt : No

Product Code : FRG

Prescription Use : No

Device Count : 144

WrapPel Wrapper - 00634916001334 Catalog Number : 27766152

Device Description : STERILE WRAP 18X18 WRAPPEL 1PL - 18X18 MERROWED-CC LAVENDER THR

Device Class :

Duns Number: 006999858

Premarket Exempt : No

Product Code : FRG

Prescription Use : No

Device Count : 144

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