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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

Platelet And Plasma Separator For Bone Graft Handling (ORG) (1)

Premarket Exempt

Clear

Eclipse Cosmetic Applicator Kit - 00853602008215 Catalog Number : MP1002-CA-K1GF

Device Description : Cosmetic Applicator Kit with GF (1 CA/pkg) - Includes a sterile, disposable cart Cosmetic Applicator Kit with GF (1 CA/pkg) - Includes a sterile, disposable cartridge tip, MicroGlide GF, and a disposable sleeve.

Device Class :

Duns Number: 969752364

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

Eclipse Cosmetic Applicator Kit - 00853602008222 Catalog Number : MP1002-CA-K1HA

Device Description : Cosmetic Applicator Kit with HA (1CA/pkg) - a sterile, disposable cartridge tip, Cosmetic Applicator Kit with HA (1CA/pkg) - a sterile, disposable cartridge tip, MicroGlide HA (topical serum), and a disposable sleeve.

Device Class :

Duns Number: 969752364

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

Eclipse MicroPen Elite - 00853602008239 Catalog Number : MP1002-II-K18CAN

Device Description : MicroPen Elite Turbo Safety Cartridge - 18TSC/Pkg (Canada)

Device Class :

Duns Number: 969752364

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

Eclipse Cosmetic Applicator Kit - 00853602008246 Catalog Number : CA-100-00-01

Device Description : Cosmetic Applicator Kit HA (12 CA / Pkg), + 2 Cosmetic Exfoliators

Device Class :

Duns Number: 969752364

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

Eclipse Cosmetic Applicator Kit - 00853602008253 Catalog Number : CA-100-00-02

Device Description : Cosmetic Applicator Kit GF (12 CA / Pkg), + 2 Cosmetic Exfoliators

Device Class :

Duns Number: 969752364

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

Eclipse Cosmetic Applicator Kit - 00853602008260 Catalog Number : MP1002-CA-K12GF-S

Device Description : Cosmetic Applicator Kit GF without MicroSleeves (12 CA / Pkg)

Device Class :

Duns Number: 969752364

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

Eclipse PRP HC - 00853602008284 Catalog Number : PRP2000-V12

Device Description : 22ml Vacutainer Holder + 21 Gauge 3/4 Inch Needle Length Safety Butterfly Needle 22ml Vacutainer Holder + 21 Gauge 3/4 Inch Needle Length Safety Butterfly Needle 12 Inch Tubing (10/Box)

Device Class :

Duns Number: 969752364

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

Eclipse PRP HC - 00853602008291 Catalog Number : PRP2700.Intl

Device Description : 22ml Blood Draw Supply Kit (International)

Device Class :

Duns Number: 969752364

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

Eclipse PRP HC - 00853602008307 Catalog Number : PRP2700-LLA

Device Description : 22ml Blood Draw Supply Kit (No Female-Female Adapter)

Device Class :

Duns Number: 969752364

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

Qigenix PRP - 00853602008321 Catalog Number : QIG1000-1

Device Description : Qigenix PRP Patient Kit - 11ml PRP Tube Only

Device Class : 2

Duns Number: 969752364

Premarket Exempt : No

Product Code : ORG

Prescription Use : Yes

Device Count : 1

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