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) (8) Component, Cast (LGF) (2)

Premarket Exempt

No Yes

Clear

Tex-Care Medical - 00632195000413 Catalog Number :

Device Description : 16X48 IMP STKT

Device Class : 2

Duns Number: 038730060

Premarket Exempt : No

Product Code : KKX

Prescription Use : No

Device Count : 1

Tex-Care Medical - 00632195000420 Catalog Number :

Device Description : 9X44 IMP STKT

Device Class : 2

Duns Number: 038730060

Premarket Exempt : No

Product Code : KKX

Prescription Use : No

Device Count : 1

Tex-Care Medical - 00632195000437 Catalog Number :

Device Description : 14X48 IMP STKT W/TABS

Device Class : 2

Duns Number: 038730060

Premarket Exempt : No

Product Code : KKX

Prescription Use : No

Device Count : 1

Tex-Care Medical - 00632195000444 Catalog Number :

Device Description : 9X48 IMP STKT W/HOOK

Device Class : 2

Duns Number: 038730060

Premarket Exempt : No

Product Code : KKX

Prescription Use : No

Device Count : 1

Tex-Care Medical - 00632195000451 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 - 00632195000468 Catalog Number :

Device Description : 8X38 IMP STKT W/HOOK/STRAPS

Device Class : 2

Duns Number: 038730060

Premarket Exempt : No

Product Code : KKX

Prescription Use : No

Device Count : 1

Tex-Care Medical - 00632195000475 Catalog Number :

Device Description : 9X30 IMP STKT W/HOOK/STRAPS

Device Class : 2

Duns Number: 038730060

Premarket Exempt : No

Product Code : KKX

Prescription Use : No

Device Count : 1

Tex-Care Medical - 00632195000482 Catalog Number :

Device Description : 9X48 IMP STKT W/HOOK/STRAPS

Device Class : 2

Duns Number: 038730060

Premarket Exempt : No

Product Code : KKX

Prescription Use : No

Device Count : 1

Tex-Care Medical - 00632195000505 Catalog Number :

Device Description : 2"X4YD NAT CAST PAD BULK PA

Device Class : 1

Duns Number: 038730060

Premarket Exempt : Yes

Product Code : LGF

Prescription Use : No

Device Count : 1

Tex-Care Medical - 00632195000529 Catalog Number :

Device Description : 3"X4YD NAT CAST PAD BULK PA

Device Class : 1

Duns Number: 038730060

Premarket Exempt : Yes

Product Code : LGF

Prescription Use : No

Device Count : 1

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