FACET TECHNOLOGIES, LLC

Address:3900 North Commerce Drive,Atlanta,GA,30344,US

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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

Needle, Hypodermic, Single Lumen (FMI) (4) Instrument, Manual, Surgical, General Use (MDM) (2) Lancet, Blood (FMK) (2) Tape And Bandage, Adhesive (KGX) (2)

Premarket Exempt

No Yes

Clear

CAREFINE - 00894743001000 Catalog Number :

Device Description : CareFine with Quintapoint Pen Needles - 6mm x 32G

Device Class :

Duns Number: 130518376

Premarket Exempt : No

Product Code : FMI

Prescription Use : No

Device Count : 100

SureSeal - 00894743001017 Catalog Number : 85100

Device Description : SureSeal Pressure Bandage, 25mm x 72mm

Device Class :

Duns Number: 130518376

Premarket Exempt : Yes

Product Code : KGX

Prescription Use : No

Device Count : 100

SureSeal - 00894743001024 Catalog Number : 85200

Device Description : SureSeal Pressure Bandage, 30mm x 72mm

Device Class :

Duns Number: 130518376

Premarket Exempt : Yes

Product Code : KGX

Prescription Use : No

Device Count : 100

CAREFINE - 00894743001147 Catalog Number :

Device Description : CareFine with Quintapoint Pen Needles - 6mm x 32G - Mail Order

Device Class :

Duns Number: 130518376

Premarket Exempt : No

Product Code : FMI

Prescription Use : No

Device Count : 90

Facet Medical Technologies - 00894743001338 Catalog Number : 0108001

Device Description : FMT Lancer Kit, CE

Device Class : 1

Duns Number: 130518376

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : No

Device Count : 1

Facet Medical Technologies - 00894743001345 Catalog Number : 0108002

Device Description : FMT Lancer

Device Class : 1

Duns Number: 130518376

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : No

Device Count : 1

Facet Medical Technologies - 00894743001369 Catalog Number : 0110001

Device Description : FMT Lancets, 30G

Device Class :

Duns Number: 130518376

Premarket Exempt : Yes

Product Code : FMK

Prescription Use : No

Device Count : 100

Facet Medcial Technologies - 00894743001376 Catalog Number : 0110002

Device Description : FMT Lancets, 33G

Device Class :

Duns Number: 130518376

Premarket Exempt : Yes

Product Code : FMK

Prescription Use : No

Device Count : 100

CAREFINE - 00894743001703 Catalog Number :

Device Description : CareFine Pen Needles - 12.7mm x 29G (3 bevel)

Device Class :

Duns Number: 130518376

Premarket Exempt : No

Product Code : FMI

Prescription Use : No

Device Count : 100

CAREFINE - 00894743001710 Catalog Number :

Device Description : CareFine Pen Needles - 6mm x 31G (3 bevel)

Device Class :

Duns Number: 130518376

Premarket Exempt : No

Product Code : FMI

Prescription Use : No

Device Count : 100

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