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

Bandage, Cast (ITG) (6) Drape, Surgical (KKX) (4)

Premarket Exempt

No Yes

Clear

Tex-Care Medical - 00632195001823 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

Tex-Care Medical - 00632195001830 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 - 00632195001847 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 - 00632195001854 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 - 00632195001861 Catalog Number :

Device Description : 2X50YD BIAS 45 BIAS PRE UNBOXED

Device Class : 1

Duns Number: 038730060

Premarket Exempt : Yes

Product Code : ITG

Prescription Use : No

Device Count : 1

Tex-Care Medical - 00632195001878 Catalog Number :

Device Description : 3X50YD 45 BIAS PRE UNBOXED

Device Class : 1

Duns Number: 038730060

Premarket Exempt : Yes

Product Code : ITG

Prescription Use : No

Device Count : 1

Tex-Care Medical - 00632195001885 Catalog Number :

Device Description : 2"X50YD BIAS CC UNBOXED

Device Class : 1

Duns Number: 038730060

Premarket Exempt : Yes

Product Code : ITG

Prescription Use : No

Device Count : 1

Tex-Care Medical - 00632195001908 Catalog Number :

Device Description : 3"X50YD BIAS CC UNBOXED

Device Class : 1

Duns Number: 038730060

Premarket Exempt : Yes

Product Code : ITG

Prescription Use : No

Device Count : 1

Tex-Care Medical - 00632195001915 Catalog Number :

Device Description : 4"X50YD BIAS CC UNBOXED

Device Class : 1

Duns Number: 038730060

Premarket Exempt : Yes

Product Code : ITG

Prescription Use : No

Device Count : 1

Tex-Care Medical - 00632195001922 Catalog Number :

Device Description : 6"X50YD BIAS CC UNBOXED

Device Class : 1

Duns Number: 038730060

Premarket Exempt : Yes

Product Code : ITG

Prescription Use : No

Device Count : 1

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