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

Cover, Limb (IPM) (5) Bandage, Cast (ITG) (3) Drape, Surgical (KKX) (2)

Premarket Exempt

No Yes

Clear

Tex-Care Medical - 00632195001939 Catalog Number :

Device Description : 3X50YD BIAS 45 DEGREE

Device Class : 1

Duns Number: 038730060

Premarket Exempt : Yes

Product Code : ITG

Prescription Use : No

Device Count : 1

Tex-Care Medical - 00632195001946 Catalog Number :

Device Description : 4X50YD BIAS 45 DEGREE

Device Class : 1

Duns Number: 038730060

Premarket Exempt : Yes

Product Code : ITG

Prescription Use : No

Device Count : 1

Tex-Care Medical - 00632195001953 Catalog Number :

Device Description : 6X50YD BIAS 45 DEGREE

Device Class : 1

Duns Number: 038730060

Premarket Exempt : Yes

Product Code : ITG

Prescription Use : No

Device Count : 1

Tex-Care Medical - 00632195001960 Catalog Number :

Device Description : 2X25 BLACK COTTON TUBULAR

Device Class : 1

Duns Number: 038730060

Premarket Exempt : Yes

Product Code : IPM

Prescription Use : No

Device Count : 1

Tex-Care Medical - 00632195001977 Catalog Number :

Device Description : 1X25 POLY ANTIMICRO

Device Class : 1

Duns Number: 038730060

Premarket Exempt : Yes

Product Code : IPM

Prescription Use : No

Device Count : 1

Tex-Care Medical - 00632195001984 Catalog Number :

Device Description : 2X25 POLY ANTIMICRO

Device Class : 1

Duns Number: 038730060

Premarket Exempt : Yes

Product Code : IPM

Prescription Use : No

Device Count : 1

Tex-Care Medical - 00632195001991 Catalog Number :

Device Description : 3X25 POLY ANTIMICRO

Device Class : 1

Duns Number: 038730060

Premarket Exempt : Yes

Product Code : IPM

Prescription Use : No

Device Count : 1

Tex-Care Medical - 00632195002004 Catalog Number :

Device Description : 4X25 POLY ANTIMICRO

Device Class : 1

Duns Number: 038730060

Premarket Exempt : Yes

Product Code : IPM

Prescription Use : No

Device Count : 1

Tex-Care Medical - 00632195002011 Catalog Number :

Device Description : 6X48 IMP STKT

Device Class : 2

Duns Number: 038730060

Premarket Exempt : No

Product Code : KKX

Prescription Use : No

Device Count : 1

Tex-Care Medical - 00632195002028 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

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