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) (6) Syringe, piston (FMF) (6) System, suction, lipoplasty (MUU) (4)

Premarket Exempt

No Yes

Clear

HARVEST® BMAC® - 05020583514249 Catalog Number :

Device Description : Bone Marrow Aspirate Concentrate (BMAC2) Procedure Pack, BMAC2-180-01 Procedure Pack

Device Class : 1

Duns Number: 801679200

Premarket Exempt : No

Product Code : FMF, JQC

Prescription Use : Yes

Device Count : 1

HARVEST® BMAC® - 05020583514256 Catalog Number :

Device Description : Bone Marrow Aspirate Concentrate (BMAC2) Procedure Pack, BMAC2-240-01 Bone Marro Bone Marrow Aspirate Concentrate (BMAC2) Procedure Pack, BMAC2-240-01 Bone Marrow Procedure Pack

Device Class : 1

Duns Number: 801679200

Premarket Exempt : No

Product Code : JQC, FMF

Prescription Use : Yes

Device Count : 1

HARVEST® BMAC® - 05020583514270 Catalog Number :

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

Device Class : 1

Duns Number: 801679200

Premarket Exempt : No

Product Code : JQC, FMF

Prescription Use : Yes

Device Count : 1

HARVEST® BMAC® 2 - 05020583514287 Catalog Number :

Device Description : Bone Marrow Aspirate Concentrate (BMAC®2) Procedure Pack, BMAC2-30n Bone Marrow Bone Marrow Aspirate Concentrate (BMAC®2) Procedure Pack, BMAC2-30n Bone Marrow Procedure Pack

Device Class : 1

Duns Number: 801679200

Premarket Exempt : No

Product Code : JQC, FMF

Prescription Use : Yes

Device Count : 1

HARVEST® BMAC® - 05020583514294 Catalog Number :

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

Device Class : 1

Duns Number: 801679200

Premarket Exempt : No

Product Code : FMF, JQC

Prescription Use : Yes

Device Count : 1

HARVEST® BMAC® - 05020583514300 Catalog Number :

Device Description : Bone Marrow Aspirate Concentrate (BMAC) Procedure Pack, BMAC2-240n Bone Marrow P Bone Marrow Aspirate Concentrate (BMAC) Procedure Pack, BMAC2-240n Bone Marrow Procedure Pack

Device Class : 1

Duns Number: 801679200

Premarket Exempt : No

Product Code : FMF, JQC

Prescription Use : Yes

Device Count : 1

HARVEST® AdiPrep® - 05020583514317 Catalog Number :

Device Description : ADI-25-01 ADIPREP Procedure Pack

Device Class : 2

Duns Number: 801679200

Premarket Exempt : No

Product Code : MUU

Prescription Use : Yes

Device Count : 1

HARVEST® AdiPrep® - 05020583514324 Catalog Number :

Device Description : ADI-25-02 ADIPREP Procedure Pack

Device Class : 2

Duns Number: 801679200

Premarket Exempt : No

Product Code : MUU

Prescription Use : Yes

Device Count : 1

HARVEST® AdiPrep® - 05020583514331 Catalog Number :

Device Description : ADI-25-03 Adipose Procedure Pack

Device Class : 2

Duns Number: 801679200

Premarket Exempt : No

Product Code : MUU

Prescription Use : Yes

Device Count : 1

HARVEST® AdiPrep® - 05020583514348 Catalog Number :

Device Description : AdiPrep® Procedure Pack , ADI-25-04 Adipose Procedure Pack

Device Class : 2

Duns Number: 801679200

Premarket Exempt : No

Product Code : MUU

Prescription Use : Yes

Device Count : 1

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