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

Component, Cast (LGF) (6) Cover, Limb (IPM) (3)

Premarket Exempt

No Yes

Clear

Tex-Care Medical - 00632195002332 Catalog Number :

Device Description : 4X100YD COTTON PRE

Device Class : 1

Duns Number: 038730060

Premarket Exempt : Yes

Product Code : IPM

Prescription Use : No

Device Count : 1

Tex-Care Medical - 00632195002349 Catalog Number :

Device Description : 6X100YD COTTON PRE

Device Class : 1

Duns Number: 038730060

Premarket Exempt : Yes

Product Code : IPM

Prescription Use : No

Device Count : 1

Tex-Care Medical - 00632195002356 Catalog Number :

Device Description : 8X100YD COTTON PRE

Device Class : 1

Duns Number: 038730060

Premarket Exempt : Yes

Product Code : IPM

Prescription Use : No

Device Count : 1

Tex-Care Medical - 00632195002462 Catalog Number :

Device Description : 4"X4YD NAT CAST PAD PKG

Device Class : 1

Duns Number: 038730060

Premarket Exempt : Yes

Product Code : LGF

Prescription Use : No

Device Count : 1

Tex-Care Medical - 00632195002479 Catalog Number :

Device Description : 6"X4YD NAT CAST PAD PKG

Device Class : 1

Duns Number: 038730060

Premarket Exempt : Yes

Product Code : LGF

Prescription Use : No

Device Count : 1

Tex-Care Medical - 00632195002486 Catalog Number :

Device Description : 2"X4YD SYN CAST PAD PKG

Device Class : 1

Duns Number: 038730060

Premarket Exempt : Yes

Product Code : LGF

Prescription Use : No

Device Count : 1

Tex-Care Medical - 00632195002493 Catalog Number :

Device Description : 3"X4YD SYN CAST PAD PKG

Device Class : 1

Duns Number: 038730060

Premarket Exempt : Yes

Product Code : LGF

Prescription Use : No

Device Count : 1

Tex-Care Medical - 00632195002509 Catalog Number :

Device Description : 4"X4YD SYN CAST PAD PKG

Device Class : 1

Duns Number: 038730060

Premarket Exempt : Yes

Product Code : LGF

Prescription Use : No

Device Count : 1

Tex-Care Medical - 00632195002516 Catalog Number :

Device Description : 6"X4YD SYN CAST PAD PKG

Device Class : 1

Duns Number: 038730060

Premarket Exempt : Yes

Product Code : LGF

Prescription Use : No

Device Count : 1

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