ARTERIOCYTE MEDICAL SYSTEMS, INC.

Address:45 South Street,Hopkinton,MA,01748,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

Biopsy Needle (FCG) (6) Instrument, Biopsy (KNW) (6) Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use (JQC) (2) Filler, Bone Void, Calcium Compound (MQV) (1)

Premarket Exempt

No Yes

Clear

Inqu - M896IQSPPP1100 Catalog Number : IQSP-PP-110

Device Class : 2

Duns Number: 809012870

Premarket Exempt : No

Product Code : MQV

Prescription Use : Yes

Device Count : 1

Lightning Needle Adapter - M896LTN010 Catalog Number :

Device Class : 2

Duns Number: 809012870

Premarket Exempt : No

Product Code : FCG, KNW

Prescription Use : Yes

Device Count : 1

Lightning Needle - M896LTN105O0 Catalog Number :

Device Class : 2

Duns Number: 809012870

Premarket Exempt : No

Product Code : FCG, KNW

Prescription Use : Yes

Device Count : 1

Lightning Needle - M896LTN25O0 Catalog Number :

Device Class : 2

Duns Number: 809012870

Premarket Exempt : No

Product Code : FCG, KNW

Prescription Use : Yes

Device Count : 1

Lightning Needle Set - M896LTN450 Catalog Number :

Device Class : 2

Duns Number: 809012870

Premarket Exempt : No

Product Code : FCG, KNW

Prescription Use : Yes

Device Count : 1

Lightning Needle - M896LTN45O0 Catalog Number :

Device Class : 2

Duns Number: 809012870

Premarket Exempt : No

Product Code : FCG, KNW

Prescription Use : Yes

Device Count : 1

Lightning Needle - M896LTN80O0 Catalog Number :

Device Class : 2

Duns Number: 809012870

Premarket Exempt : No

Product Code : FCG, KNW

Prescription Use : Yes

Device Count : 1

Platelet Separation Chamber - M896M932793A0010 Catalog Number : M932793A0010

Device Description : Sterile Disposable Kit containing single-patient-use components necessary for ea Sterile Disposable Kit containing single-patient-use components necessary for each platelet separation procedure with the MAGELLAN® Autologous Platelet Separator Instrument.

Device Class :

Duns Number: 809012870

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

Autologous Platelet Separator - M896MAG1000 Catalog Number : MAG100

Device Description : MAGELLAN® Autologous Platelet Separator System consists of the Platelet Separato MAGELLAN® Autologous Platelet Separator System consists of the Platelet Separator Instrument and the associated Platelet Rich Plasma Sterile Disposable Kits.

Device Class : 1

Duns Number: 809012870

Premarket Exempt : No

Product Code : JQC

Prescription Use : Yes

Device Count : 1

Autologous Platelet Separator - M896MAG2000 Catalog Number : MAG200

Device Class : 1

Duns Number: 809012870

Premarket Exempt : No

Product Code : JQC

Prescription Use : Yes

Device Count : 1

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