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) (9) Cover, Limb (IPM) (1)

Premarket Exempt

No Yes

Clear

Tex-Care Medical - 00632195000697 Catalog Number :

Device Description : 4X3 COTTON BIAS

Device Class : 1

Duns Number: 038730060

Premarket Exempt : Yes

Product Code : ITG

Prescription Use : No

Device Count : 1

Tex-Care Medical - 00632195000703 Catalog Number :

Device Description : 4X4 COTTON BIAS

Device Class : 1

Duns Number: 038730060

Premarket Exempt : Yes

Product Code : ITG

Prescription Use : No

Device Count : 1

Tex-Care Medical - 00632195000710 Catalog Number :

Device Description : 4X5 COTTON BIAS

Device Class : 1

Duns Number: 038730060

Premarket Exempt : Yes

Product Code : ITG

Prescription Use : No

Device Count : 1

Tex-Care Medical - 00632195000727 Catalog Number :

Device Description : 6X3 COTTON BIAS

Device Class : 1

Duns Number: 038730060

Premarket Exempt : Yes

Product Code : ITG

Prescription Use : No

Device Count : 1

Tex-Care Medical - 00632195000734 Catalog Number :

Device Description : 6X4 COTTON BIAS

Device Class : 1

Duns Number: 038730060

Premarket Exempt : Yes

Product Code : ITG

Prescription Use : No

Device Count : 1

Tex-Care Medical - 00632195000741 Catalog Number :

Device Description : 6X5 COTTON BIAS

Device Class : 1

Duns Number: 038730060

Premarket Exempt : Yes

Product Code : ITG

Prescription Use : No

Device Count : 1

Tex-Care Medical - 00632195000758 Catalog Number :

Device Description : 6X8 COTTON BIAS

Device Class : 1

Duns Number: 038730060

Premarket Exempt : Yes

Product Code : ITG

Prescription Use : No

Device Count : 1

Tex-Care Medical - 00632195000765 Catalog Number :

Device Description : 8X4 COTTON BIAS

Device Class : 1

Duns Number: 038730060

Premarket Exempt : Yes

Product Code : ITG

Prescription Use : No

Device Count : 1

Tex-Care Medical - 00632195000772 Catalog Number :

Device Description : 8X5 COTTON BIAS

Device Class : 1

Duns Number: 038730060

Premarket Exempt : Yes

Product Code : ITG

Prescription Use : No

Device Count : 1

Tex-Care Medical - 00632195000789 Catalog Number :

Device Description : 4X36 SP STKT

Device Class : 1

Duns Number: 038730060

Premarket Exempt : Yes

Product Code : IPM

Prescription Use : No

Device Count : 1

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