TERUMO BCT, INC.

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

Syringe, piston (FMF) (7) CENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE (JQC) (1) Platelet and plasma separator for bone graft handling (ORG) (1) System, suction, lipoplasty (MUU) (1)

Premarket Exempt

No Yes

Clear

HARVEST® AdiPrep® - 05020583514355 Catalog Number :

Device Description : ADI-25-05 ADIPREP Procedure Pack

Device Class : 2

Duns Number: 801679200

Premarket Exempt : No

Product Code : MUU

Prescription Use : Yes

Device Count : 1

HARVEST® - 05020583514362 Catalog Number :

Device Description : Autologous Platelet Concentrate+ (APC+) Procedure Pack, APC-120n PRP Procedure Pack

Device Class :

Duns Number: 801679200

Premarket Exempt : No

Product Code : ORG

Prescription Use : Yes

Device Count : 1

HARVEST® - 05020583514478 Catalog Number :

Device Description : BBAN-10 Needles(BMAC/BMAC2)11Ga X 110mm

Device Class :

Duns Number: 801679200

Premarket Exempt : No

Product Code : FMF

Prescription Use : Yes

Device Count : 1

HARVEST® - 05020583514485 Catalog Number :

Device Description : BAN-25 8Ga BM Aspirate Needle

Device Class :

Duns Number: 801679200

Premarket Exempt : No

Product Code : FMF

Prescription Use : Yes

Device Count : 1

HARVEST® - 05020583514492 Catalog Number :

Device Description : Graft Delivery Pack

Device Class :

Duns Number: 801679200

Premarket Exempt : No

Product Code : FMF

Prescription Use : Yes

Device Count : 1

HARVEST® SmartJet® - 05020583514515 Catalog Number :

Device Description : SmartJet® Dual Liquid Applicator Kit, SK/S SmartJet Spray Applicator Kit

Device Class :

Duns Number: 801679200

Premarket Exempt : No

Product Code : FMF

Prescription Use : Yes

Device Count : 1

HARVEST® SmartJet® - 05020583514522 Catalog Number :

Device Description : SmartJet® Dual Liquid Applicator Kit, LK/4Dual Liquid Applicator Kit, 2IN

Device Class :

Duns Number: 801679200

Premarket Exempt : No

Product Code : FMF

Prescription Use : Yes

Device Count : 1

HARVEST® SmartJet® - 05020583514539 Catalog Number :

Device Description : SmartJet Dual Liquid Applicator Kit, KLK/4 dual Liquid Applicator Kit, 4 IN

Device Class :

Duns Number: 801679200

Premarket Exempt : No

Product Code : FMF

Prescription Use : Yes

Device Count : 1

HARVEST® SmartJet® - 05020583514546 Catalog Number :

Device Description : SmartJet® Dual Liquid Applicator Kit, LK/7 SmartJet 7 in. Liquid App. Kit

Device Class :

Duns Number: 801679200

Premarket Exempt : No

Product Code : FMF

Prescription Use : Yes

Device Count : 1

HARVEST® SmartPrep® - 05020583514706 Catalog Number :

Device Description : SmartPRep® 2 Centrifuge System, Two Place Rotor

Device Class : 1

Duns Number: 801679200

Premarket Exempt : No

Product Code : JQC

Prescription Use : Yes

Device Count : 1

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