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 - 00632195002035 Catalog Number :

Device Description : 6X72 DP POLY

Device Class : 1

Duns Number: 038730060

Premarket Exempt : Yes

Product Code : IPM

Prescription Use : No

Device Count : 1

Tex-Care Medical - 00632195002042 Catalog Number :

Device Description : 4X48 SP POLY

Device Class : 1

Duns Number: 038730060

Premarket Exempt : Yes

Product Code : IPM

Prescription Use : No

Device Count : 1

Tex-Care Medical - 00632195002059 Catalog Number :

Device Description : 6X48 SP POLY

Device Class : 1

Duns Number: 038730060

Premarket Exempt : Yes

Product Code : IPM

Prescription Use : No

Device Count : 1

Tex-Care Medical - 00632195002066 Catalog Number :

Device Description : 6X60 SP POLY

Device Class : 1

Duns Number: 038730060

Premarket Exempt : Yes

Product Code : IPM

Prescription Use : No

Device Count : 1

Tex-Care Medical - 00632195002073 Catalog Number :

Device Description : 4X36 DP POLY

Device Class : 1

Duns Number: 038730060

Premarket Exempt : Yes

Product Code : IPM

Prescription Use : No

Device Count : 1

Tex-Care Medical - 00632195002080 Catalog Number :

Device Description : 4X48 DP POLY

Device Class : 1

Duns Number: 038730060

Premarket Exempt : Yes

Product Code : IPM

Prescription Use : No

Device Count : 1

Tex-Care Medical - 00632195002097 Catalog Number :

Device Description : 6X48 DP POLY

Device Class : 1

Duns Number: 038730060

Premarket Exempt : Yes

Product Code : IPM

Prescription Use : No

Device Count : 1

Tex-Care Medical - 00632195002103 Catalog Number :

Device Description : 6X60 DP POLY

Device Class : 1

Duns Number: 038730060

Premarket Exempt : Yes

Product Code : IPM

Prescription Use : No

Device Count : 1

Tex-Care Medical - 00632195002110 Catalog Number :

Device Description : 8X72 DP POLY

Device Class : 1

Duns Number: 038730060

Premarket Exempt : Yes

Product Code : IPM

Prescription Use : No

Device Count : 1

Tex-Care Medical - 00632195002127 Catalog Number :

Device Description : 12X100YD POLY

Device Class : 1

Duns Number: 038730060

Premarket Exempt : Yes

Product Code : IPM

Prescription Use : No

Device Count : 1

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