Flynt/Amtex, Inc.

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) (8) Bandage, Cast (ITG) (2)

Premarket Exempt

No Yes

Clear

Tex-Care Medical - 00632195000000 Catalog Number :

Device Description : 6X50 COTTON BIAS

Device Class : 1

Duns Number: 038730060

Premarket Exempt : Yes

Product Code : ITG

Prescription Use : No

Device Count : 1

Tex-Care Medical - 00632195000017 Catalog Number :

Device Description : 8X50 COTTON BIAS

Device Class : 1

Duns Number: 038730060

Premarket Exempt : Yes

Product Code : ITG

Prescription Use : No

Device Count : 1

Tex-Care Medical - 00632195000024 Catalog Number :

Device Description : 1X25 COTTON TUBULAR

Device Class : 1

Duns Number: 038730060

Premarket Exempt : Yes

Product Code : IPM

Prescription Use : No

Device Count : 1

Tex-Care Medical - 00632195000031 Catalog Number :

Device Description : 2X25 COTTON TUBULAR

Device Class : 1

Duns Number: 038730060

Premarket Exempt : Yes

Product Code : IPM

Prescription Use : No

Device Count : 1

Tex-Care Medical - 00632195000048 Catalog Number :

Device Description : 3X25 COTTON TUBULAR

Device Class : 1

Duns Number: 038730060

Premarket Exempt : Yes

Product Code : IPM

Prescription Use : No

Device Count : 1

Tex-Care Medical - 00632195000055 Catalog Number :

Device Description : 4X25 COTTON TUBULAR

Device Class : 1

Duns Number: 038730060

Premarket Exempt : Yes

Product Code : IPM

Prescription Use : No

Device Count : 1

Tex-Care Medical - 00632195000062 Catalog Number :

Device Description : 5X25 COTTON TUBULAR

Device Class : 1

Duns Number: 038730060

Premarket Exempt : Yes

Product Code : IPM

Prescription Use : No

Device Count : 1

Tex-Care Medical - 00632195000079 Catalog Number :

Device Description : 6X25 COTTON TUBULAR

Device Class : 1

Duns Number: 038730060

Premarket Exempt : Yes

Product Code : IPM

Prescription Use : No

Device Count : 1

Tex-Care Medical - 00632195000086 Catalog Number :

Device Description : 8X25 COTTON TUBULAR

Device Class : 1

Duns Number: 038730060

Premarket Exempt : Yes

Product Code : IPM

Prescription Use : No

Device Count : 1

Tex-Care Medical - 00632195000093 Catalog Number :

Device Description : 10X25 COTTON TUBULAR

Device Class : 1

Duns Number: 038730060

Premarket Exempt : Yes

Product Code : IPM

Prescription Use : No

Device Count : 1

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