Regenlab USA LLC

Address:140 58th Street 2nd Floor,Brooklyn,NY,11220,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) (3) Syringe, Piston (FMF) (2) Needle, Hypodermic, Single Lumen (FMI) (1)

Premarket Exempt

No Yes

Clear

Accessory Set - 00850033131017 Catalog Number :

Device Class :

Duns Number: 087434117

Premarket Exempt : Yes

Product Code :

Prescription Use : Yes

Device Count : 1

Accessory Set - 00850033131024 Catalog Number :

Device Class :

Duns Number: 087434117

Premarket Exempt : Yes

Product Code :

Prescription Use : Yes

Device Count : 1

A-CP-Kit-3 - 08500331310011 Catalog Number :

Device Class : 2

Duns Number: 087434117

Premarket Exempt : No

Product Code : ORG

Prescription Use : Yes

Device Count : 1

Accessory Set - 08500331310028 Catalog Number :

Device Class :

Duns Number: 087434117

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

Accessory Set - 08500331310035 Catalog Number :

Device Class :

Duns Number: 087434117

Premarket Exempt : Yes

Product Code :

Prescription Use : Yes

Device Count : 1

RegenKit®-BCT-1 - 08500331310042 Catalog Number :

Device Class : 2

Duns Number: 087434117

Premarket Exempt : No

Product Code : ORG

Prescription Use : Yes

Device Count : 1

RegenKit®-BCT-3 - 08500331310066 Catalog Number :

Device Class : 2

Duns Number: 087434117

Premarket Exempt : No

Product Code : ORG

Prescription Use : Yes

Device Count : 1

RegenKit®-THT-3 - 08500331310073 Catalog Number :

Device Class : 2

Duns Number: 087434117

Premarket Exempt : No

Product Code : FMI, FMF

Prescription Use : Yes

Device Count : 1

Regen Spray Applicator - 08500331310110 Catalog Number :

Device Class : 2

Duns Number: 087434117

Premarket Exempt : No

Product Code : FMF

Prescription Use : Yes

Device Count : 1

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