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) (10)

Premarket Exempt

No Yes

Clear

Tex-Care Medical - 00632195002134 Catalog Number :

Device Description : 2X50YD POLY

Device Class : 1

Duns Number: 038730060

Premarket Exempt : Yes

Product Code : IPM

Prescription Use : No

Device Count : 1

Tex-Care Medical - 00632195002141 Catalog Number :

Device Description : 3X100YD POLY

Device Class : 1

Duns Number: 038730060

Premarket Exempt : Yes

Product Code : IPM

Prescription Use : No

Device Count : 1

Tex-Care Medical - 00632195002158 Catalog Number :

Device Description : 4X100YD POLY

Device Class : 1

Duns Number: 038730060

Premarket Exempt : Yes

Product Code : IPM

Prescription Use : No

Device Count : 1

Tex-Care Medical - 00632195002165 Catalog Number :

Device Description : 6X100YD POLY

Device Class : 1

Duns Number: 038730060

Premarket Exempt : Yes

Product Code : IPM

Prescription Use : No

Device Count : 1

Tex-Care Medical - 00632195002172 Catalog Number :

Device Description : 8X100YD POLY

Device Class : 1

Duns Number: 038730060

Premarket Exempt : Yes

Product Code : IPM

Prescription Use : No

Device Count : 1

Tex-Care Medical - 00632195002189 Catalog Number :

Device Description : 9X100YD POLY

Device Class : 1

Duns Number: 038730060

Premarket Exempt : Yes

Product Code : IPM

Prescription Use : No

Device Count : 1

Tex-Care Medical - 00632195002196 Catalog Number :

Device Description : 2X25 COTTON W/POLYBAG

Device Class : 1

Duns Number: 038730060

Premarket Exempt : Yes

Product Code : IPM

Prescription Use : No

Device Count : 1

Tex-Care Medical - 00632195002202 Catalog Number :

Device Description : 2X50YD COTTON

Device Class : 1

Duns Number: 038730060

Premarket Exempt : Yes

Product Code : IPM

Prescription Use : No

Device Count : 1

Tex-Care Medical - 00632195002219 Catalog Number :

Device Description : 3X100YD COTTON

Device Class : 1

Duns Number: 038730060

Premarket Exempt : Yes

Product Code : IPM

Prescription Use : No

Device Count : 1

Tex-Care Medical - 00632195002226 Catalog Number :

Device Description : 4X100YD COTTON

Device Class : 1

Duns Number: 038730060

Premarket Exempt : Yes

Product Code : IPM

Prescription Use : No

Device Count : 1

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