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 - 00632195000796 Catalog Number :

Device Description : 4X48 SP STKT

Device Class : 1

Duns Number: 038730060

Premarket Exempt : Yes

Product Code : IPM

Prescription Use : No

Device Count : 1

Tex-Care Medical - 00632195000802 Catalog Number :

Device Description : 4X60 SP STKT

Device Class : 1

Duns Number: 038730060

Premarket Exempt : Yes

Product Code : IPM

Prescription Use : No

Device Count : 1

Tex-Care Medical - 00632195000819 Catalog Number :

Device Description : 6X36 SP STKT

Device Class : 1

Duns Number: 038730060

Premarket Exempt : Yes

Product Code : IPM

Prescription Use : No

Device Count : 1

Tex-Care Medical - 00632195000826 Catalog Number :

Device Description : 6X48 SP STKT

Device Class : 1

Duns Number: 038730060

Premarket Exempt : Yes

Product Code : IPM

Prescription Use : No

Device Count : 1

Tex-Care Medical - 00632195000833 Catalog Number :

Device Description : 6X60 SP STKT

Device Class : 1

Duns Number: 038730060

Premarket Exempt : Yes

Product Code : IPM

Prescription Use : No

Device Count : 1

Tex-Care Medical - 00632195000840 Catalog Number :

Device Description : 6X72 SP STKT

Device Class : 1

Duns Number: 038730060

Premarket Exempt : Yes

Product Code : IPM

Prescription Use : No

Device Count : 1

Tex-Care Medical - 00632195000857 Catalog Number :

Device Description : 8X60 SP STKT

Device Class : 1

Duns Number: 038730060

Premarket Exempt : Yes

Product Code : IPM

Prescription Use : No

Device Count : 1

Tex-Care Medical - 00632195000864 Catalog Number :

Device Description : 8X72 SP STKT

Device Class : 1

Duns Number: 038730060

Premarket Exempt : Yes

Product Code : IPM

Prescription Use : No

Device Count : 1

Tex-Care Medical - 00632195000871 Catalog Number :

Device Description : 3X25 DP STKT

Device Class : 1

Duns Number: 038730060

Premarket Exempt : Yes

Product Code : IPM

Prescription Use : No

Device Count : 1

Tex-Care Medical - 00632195000888 Catalog Number :

Device Description : 3X36 DP STKT

Device Class : 1

Duns Number: 038730060

Premarket Exempt : Yes

Product Code : IPM

Prescription Use : No

Device Count : 1

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