Flynt/Amtex, Inc.

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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) (10)

Premarket Exempt

No Yes

Clear

Tex-Care Medical - 00632195000314 Catalog Number :

Device Description : 9X48 IMP STKT

Device Class : 2

Duns Number: 038730060

Premarket Exempt : No

Product Code : KKX

Prescription Use : No

Device Count : 1

Tex-Care Medical - 00632195000321 Catalog Number :

Device Description : 12X48 IMP STKT

Device Class : 2

Duns Number: 038730060

Premarket Exempt : No

Product Code : KKX

Prescription Use : No

Device Count : 1

Tex-Care Medical - 00632195000338 Catalog Number :

Device Description : 6X30 IMP STKT

Device Class : 2

Duns Number: 038730060

Premarket Exempt : No

Product Code : KKX

Prescription Use : No

Device Count : 1

Tex-Care Medical - 00632195000345 Catalog Number :

Device Description : 8X38 IMP STKT

Device Class : 2

Duns Number: 038730060

Premarket Exempt : No

Product Code : KKX

Prescription Use : No

Device Count : 1

Tex-Care Medical - 00632195000352 Catalog Number :

Device Description : 8X48 IMP STKT

Device Class : 2

Duns Number: 038730060

Premarket Exempt : No

Product Code : KKX

Prescription Use : No

Device Count : 1

Tex-Care Medical - 00632195000369 Catalog Number :

Device Description : 9X36 IMP STKT

Device Class : 2

Duns Number: 038730060

Premarket Exempt : No

Product Code : KKX

Prescription Use : No

Device Count : 1

Tex-Care Medical - 00632195000376 Catalog Number :

Device Description : 10X48 IMP STKT

Device Class : 2

Duns Number: 038730060

Premarket Exempt : No

Product Code : KKX

Prescription Use : No

Device Count : 1

Tex-Care Medical - 00632195000383 Catalog Number :

Device Description : 12X54 IMP STKT

Device Class : 2

Duns Number: 038730060

Premarket Exempt : No

Product Code : KKX

Prescription Use : No

Device Count : 1

Tex-Care Medical - 00632195000390 Catalog Number :

Device Description : 12X60 IMP STKT

Device Class : 2

Duns Number: 038730060

Premarket Exempt : No

Product Code : KKX

Prescription Use : No

Device Count : 1

Tex-Care Medical - 00632195000406 Catalog Number :

Device Description : 14X48 IMP STKT

Device Class : 2

Duns Number: 038730060

Premarket Exempt : No

Product Code : KKX

Prescription Use : No

Device Count : 1

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