ECLIPSE

Address:5916 Stone Creek Dr.,The Colony,TX,75056,US

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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) (7) Powered Microneedle Device (QAI) (1)

Premarket Exempt

Clear

Eclipse DermaFlex MicroCannula - 00853602008482 Catalog Number : DF25G50MM23G

Device Description : DermaFlex Microcannula 25G/50mm + 23G/25mm Pilot

Device Class : 2

Duns Number: 969752364

Premarket Exempt : No

Product Code : FMI

Prescription Use : Yes

Device Count : 1

Eclipse DermaFlex MicroCannula - 00853602008499 Catalog Number : DF27G25MM26G

Device Description : DermaFlex Microcannula 27G/25mm + 26G/25mm Pilot

Device Class : 2

Duns Number: 969752364

Premarket Exempt : No

Product Code : FMI

Prescription Use : Yes

Device Count : 1

Eclipse DermaFlex MicroCannula - 00853602008505 Catalog Number : DF27G38MM26G

Device Description : DermaFlex Microcannula 27G/38mm + 26G/25mm Pilot

Device Class : 2

Duns Number: 969752364

Premarket Exempt : No

Product Code : FMI

Prescription Use : Yes

Device Count : 1

Eclipse DermaFlex MicroCannula - 00853602008512 Catalog Number :

Device Description : DermaFlex Microcannula 27G/50mm + 26G/25mm Pilot

Device Class : 2

Duns Number: 969752364

Premarket Exempt : No

Product Code : FMI

Prescription Use : Yes

Device Count : 1

Eclipse DermaFlex MicroCannula - 00853602008529 Catalog Number : DF30G25MM27G

Device Description : DermaFlex Microcannula 30G/25mm + 27G/25mm Pilot

Device Class : 2

Duns Number: 969752364

Premarket Exempt : No

Product Code : FMI

Prescription Use : Yes

Device Count : 1

Eclipse MicroPen EVO - 00853602008598 Catalog Number : 50EVO1000-010

Device Description : Eclipse MicroPen EVO handpiece which is an automated, non-surgical microneedling Eclipse MicroPen EVO handpiece which is an automated, non-surgical microneedling device designed for use by licensed healthcare practitioners or individuals directed by practitioners.

Device Class :

Duns Number: 969752364

Premarket Exempt : No

Product Code : QAI

Prescription Use : Yes

Device Count : 1

Eclipse Hypodermic Needle - 18G - 00853602008604 Catalog Number :

Device Description : Eclipse 18 Gauge Venting Needle - 18G x 1"; sterilized and individually packaged Eclipse 18 Gauge Venting Needle - 18G x 1"; sterilized and individually packaged for single patient use. Venting needle is a component within the Eclipse PRP 22mL Patient Kit.

Device Class : 2

Duns Number: 969752364

Premarket Exempt : No

Product Code : FMI

Prescription Use : Yes

Device Count : 1

Eclipse Hypodermic Needle - 30G - 00853602008611 Catalog Number : 50PRP2500-N30gx13mm

Device Description : Eclipse 30G Hypodermic Needle - 30G x 0.5"; sterilized and individually packaged Eclipse 30G Hypodermic Needle - 30G x 0.5"; sterilized and individually packaged for single patient use.

Device Class : 2

Duns Number: 969752364

Premarket Exempt : No

Product Code : FMI

Prescription Use : Yes

Device Count : 1

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