Terumo BCT, Inc.

UDI Case 35020583514493, Each 05020583514492  Batch/Number: 04A9925, Exp. 01MAR2018; 05A9928, Exp. 01MAY2019; 06A9948, Exp. 01JUN2019; 06A9978, Exp. 01JUN2019; 08A9950, Exp. 01AUG2019

General Hospital and Personal Use Devices

2

No

Nationwide Distribution including CA, CO, GA, LA, NJ, NV, NY, OR, PA, TX, and UT.

HARVEST TERUMOBCT, GCP-10 Graft Delivery Pack, REF 51449, Rx Only, STERILE EO || Harvest Graph Delivery System is a disposable pack that takes the cell concentrate created while using the BMAC Procedure Packs and allows for hydration of bone graft material for application to the sites doctors deem necessary

UDI Case: 35020583514233, 51423 Each: 05020583514232, Lot 04A9939

Clinical Chemistry and Clinical Toxicology Devices

1

No

CA, Co, MO, NY, PA, TX, VA, WI, Turkey, Austria, Spain

HARVEST(R) TERUMOBCT, BMAC2-120-01Bone Marrow Procedure Pack, REF 51423, Rx Only, STERILE EO

Lot 04A9938

Clinical Chemistry and Clinical Toxicology Devices

1

No

CA, Co, MO, NY, PA, TX, VA, WI, Turkey, Austria, Spain

HARVEST(R) TERUMOBCT, BMAC-30-07 Bone Marrow Procedure Pack, Private Practice / Clinical Use Only, REF 51416, Rx Only, STERILE EO

Product Code: 51431, Lot Codes: 07Z9913; 07Z9933; 08Z9932; 09Z9908; 10Z9908 Product Code: 51432, Lot Codes: 08Z9907; 09Z9931. Product Code: 51433, Lot Codes: 08Z9901; 08Z9933. Product Code: 514001-347, Lot Codes: 05Z9956; 05Z9956; 07Z9917; 07Z9917; 07Z9917; 07Z9917; 05Z9956; 05Z9956; 07Z9917

General and Plastic Surgery Devices

2

No

Nationwide, Canadian, and other foreign consignees. No VA/govt/military consignees.

Adiprep Adipose Transfer System. Product Codes: 51431; 51432; 51433; 514001-347.