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) (6) Drape, Surgical (KKX) (3) Cover, Limb (IPM) (1)

Premarket Exempt

No Yes

Clear

Tex-Care Medical - 00632195000208 Catalog Number :

Device Description : 2X50YD BIAS

Device Class : 1

Duns Number: 038730060

Premarket Exempt : Yes

Product Code : ITG

Prescription Use : No

Device Count : 1

Tex-Care Medical - 00632195000215 Catalog Number :

Device Description : 3X50YD BIAS

Device Class :

Duns Number: 038730060

Premarket Exempt : Yes

Product Code : ITG

Prescription Use : No

Device Count : 1

Tex-Care Medical - 00632195000222 Catalog Number :

Device Description : 4X50YD BIAS

Device Class : 1

Duns Number: 038730060

Premarket Exempt : Yes

Product Code : ITG

Prescription Use : No

Device Count : 1

Tex-Care Medical - 00632195000239 Catalog Number :

Device Description : 5X50YD BIAS

Device Class : 1

Duns Number: 038730060

Premarket Exempt : Yes

Product Code : ITG

Prescription Use : No

Device Count : 1

Tex-Care Medical - 00632195000246 Catalog Number :

Device Description : 6X50YD BIAS

Device Class : 1

Duns Number: 038730060

Premarket Exempt : Yes

Product Code : ITG

Prescription Use : No

Device Count : 1

Tex-Care Medical - 00632195000253 Catalog Number :

Device Description : 8X50YD BIAS

Device Class : 1

Duns Number: 038730060

Premarket Exempt : Yes

Product Code : ITG

Prescription Use : No

Device Count : 1

Tex-Care Medical - 00632195000260 Catalog Number :

Device Description : 2X36 SP STKT

Device Class : 1

Duns Number: 038730060

Premarket Exempt : Yes

Product Code : IPM

Prescription Use : No

Device Count : 1

Tex-Care Medical - 00632195000284 Catalog Number :

Device Description : 12X48 IMP STKT

Device Class : 2

Duns Number: 038730060

Premarket Exempt : No

Product Code : KKX

Prescription Use : No

Device Count : 1

Tex-Care Medical - 00632195000291 Catalog Number :

Device Description : 9X30 IMP STKT

Device Class : 2

Duns Number: 038730060

Premarket Exempt : No

Product Code : KKX

Prescription Use : No

Device Count : 1

Tex-Care Medical - 00632195000307 Catalog Number :

Device Description : 6X48 IMP STKT

Device Class : 2

Duns Number: 038730060

Premarket Exempt : No

Product Code : KKX

Prescription Use : No

Device Count : 1

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