TERUMO BCT, INC.

Address:10811 W COLLINS AVE,Lakewood,CO,80215,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

CENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE (JQC) (7) Syringe, piston (FMF) (7) Platelet and plasma separator for bone graft handling (ORG) (3)

Premarket Exempt

No Yes

Clear

HARVEST® - 05020583514102 Catalog Number :

Device Description : LP-10 Clear PRP Kit

Device Class :

Duns Number: 801679200

Premarket Exempt : No

Product Code : ORG

Prescription Use : Yes

Device Count : 1

HARVEST® - 05020583514140 Catalog Number :

Device Description : Autologous Platelet Concentrate+ (APC+) Procedure Pack, APC-30n PRP Procedure Pack

Device Class :

Duns Number: 801679200

Premarket Exempt : No

Product Code : ORG

Prescription Use : Yes

Device Count : 1

HARVEST® - 05020583514157 Catalog Number :

Device Description : Autologous Platelet Concentrate+ (APC+) Procedure Pack, APC-60n PRP Procedure Pack

Device Class :

Duns Number: 801679200

Premarket Exempt : No

Product Code : ORG

Prescription Use : Yes

Device Count : 1

HARVEST® BMAC® - 05020583514164 Catalog Number :

Device Description : Bone Marrow Aspirate Concentrate (BMAC) Procedure PackBMAC-30-07 Procedure Pack

Device Class : 1

Duns Number: 801679200

Premarket Exempt : No

Product Code : JQC, FMF

Prescription Use : Yes

Device Count : 1

HARVEST® BMAC® - 05020583514171 Catalog Number :

Device Description : Bone Marrow Aspirate Concentrate (BMAC) Procedure Pack, BMAC-60-07 Procedure Pack

Device Class : 1

Duns Number: 801679200

Premarket Exempt : No

Product Code : FMF, JQC

Prescription Use : Yes

Device Count : 1

HARVEST® BMAC® - 05020583514188 Catalog Number :

Device Description : Bone Marrow Aspirate Concentrate (BMAC) Procedure Pack, BMAC-120-07 Procedure Pack

Device Class : 1

Duns Number: 801679200

Premarket Exempt : No

Product Code : JQC, FMF

Prescription Use : Yes

Device Count : 1

HARVEST® BMAC® 2 - 05020583514201 Catalog Number :

Device Description : Bone Marrow Aspirate Concentrate (BMAC2) Procedure Pack, BMAC2-30-01 Procedure Pack

Device Class : 1

Duns Number: 801679200

Premarket Exempt : No

Product Code : FMF, JQC

Prescription Use : Yes

Device Count : 1

HARVEST® BMAC® - 05020583514218 Catalog Number :

Device Description : Bone Marrow Aspirate Concentrate (BMAC2) Procedure Pack, BMAC2-30-02 Procedure Pack

Device Class : 1

Duns Number: 801679200

Premarket Exempt : No

Product Code : JQC, FMF

Prescription Use : Yes

Device Count : 1

HARVEST® BMAC® 2 - 05020583514225 Catalog Number :

Device Description : Bone Marrow Aspirate Concentrate (BMAC2) Procedure Pack, BMAC2-60-01 Procedure Pack

Device Class : 1

Duns Number: 801679200

Premarket Exempt : No

Product Code : JQC, FMF

Prescription Use : Yes

Device Count : 1

HARVEST® BMAC® - 05020583514232 Catalog Number :

Device Description : Bone Marrow Aspirate Concentrate (BMAC2) Procedure Pack, BMAC2-120-01 Procedure Pack

Device Class : 1

Duns Number: 801679200

Premarket Exempt : No

Product Code : JQC, FMF

Prescription Use : Yes

Device Count : 1

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