Bellus Medical, LLC

Address:5005 Lyndon B. Johnson Frwy.,Dallas,TX,75244,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

Platelet And Plasma Separator For Bone Graft Handling (ORG) (4) Powered Microneedle Device (QAI) (4) Blood Specimen Collection Convenience Kit (Excludes Hiv) (PQD) (2)

Premarket Exempt

No Yes

Clear

SP MicroPen EVO - 00850035498262 Catalog Number :

Device Description : MicroPen EVO Microneedling Device

Device Class : 2

Duns Number: 005677967

Premarket Exempt : No

Product Code : QAI

Prescription Use : Yes

Device Count : 1

SP MicroPen EVO Microneedling Cartridge - 00850035498279 Catalog Number :

Device Description : MicroPen EVO Turbo Safety Cartridge (each). Cartridges are sterilized and packag MicroPen EVO Turbo Safety Cartridge (each). Cartridges are sterilized and packaged individually for single patient use.

Device Class :

Duns Number: 005677967

Premarket Exempt : No

Product Code : QAI

Prescription Use : Yes

Device Count : 1

Progen PRP Advantage - 00850035498378 Catalog Number : F5PG013.02

Device Description : 15 mL Blood Draw Kit - Single

Device Class : 2

Duns Number: 005677967

Premarket Exempt : Yes

Product Code : PQD

Prescription Use : Yes

Device Count : 1

Progen PRP Advantage - 00850035498385 Catalog Number : F5PG014.02

Device Description : 30 ml Blood Draw Kits

Device Class : 2

Duns Number: 005677967

Premarket Exempt : Yes

Product Code : PQD

Prescription Use : Yes

Device Count : 1

Progen PRP Advantage - 00850035498415 Catalog Number :

Device Description : Progen PRP Advantage Kits - 15 ml PRP Tubes and Blood Draw Kit

Device Class : 2

Duns Number: 005677967

Premarket Exempt : Yes

Product Code : ORG

Prescription Use : Yes

Device Count : 1

Progen PRP Advantage - 00850035498422 Catalog Number :

Device Description : Progen PRP Advantage Kits - 30 ml PRP Tubes and Blood Draw Kit

Device Class : 2

Duns Number: 005677967

Premarket Exempt : Yes

Product Code : ORG

Prescription Use : Yes

Device Count : 1

Progen PRP Advantage - 00850035498439 Catalog Number :

Device Description : Progen PRP Advantage Kits - 15 ml PRP tubes and Blood Draw Kit

Device Class : 2

Duns Number: 005677967

Premarket Exempt : Yes

Product Code : ORG

Prescription Use : Yes

Device Count : 1

Progen PRP Advantage - 00850035498446 Catalog Number :

Device Description : Progen PRP Advantage Kits - 30 ml PRP Tubes and Blood Draw Kit

Device Class : 2

Duns Number: 005677967

Premarket Exempt : Yes

Product Code : ORG

Prescription Use : Yes

Device Count : 1

SkinPen - 00863221000309 Catalog Number :

Device Description : SkinPen Precision Microneedling Cartridge

Device Class : 2

Duns Number: 005677967

Premarket Exempt : No

Product Code : QAI

Prescription Use : Yes

Device Count : 1

SkinPen - 00863221000316 Catalog Number :

Device Class : 2

Duns Number: 005677967

Premarket Exempt : No

Product Code : QAI

Prescription Use : Yes

Device Count : 1

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