DEVICE: HARVEST® SmartPrep® (05020583514751)
Device Identifier (DI) Information
HARVEST® SmartPrep®
51475
Not in Commercial Distribution
TERUMO BCT, INC.
51475
Not in Commercial Distribution
TERUMO BCT, INC.
SmartPrep® 3 Multi-Cellular Processing System
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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47154 | Haematological concentrate system centrifuge |
An electrically-powered device typically intended to be used at the point-of-care to concentrate platelets or bone marrow aspirate cells from a small volume of autologous (patient's own) blood/bone marrow using centrifugal force, for the rapid preparation of platelet-rich plasma (PRP) or bone marrow aspirate concentrate (BMAC). The concentrates are applied to general and orthopaedic surgical sites, or pre-mixed with graft material, to assist the healing and/or graft acceptance process. It includes a rotor head with a receptacle(s) for dedicated autologous specimen processing equipment. This device may additionally have refrigeration capabilities to perform temperature-sensitive procedures.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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JQC | CENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between -40 and 66 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
9c620a95-65ed-4586-bdbf-9579c47f270f
September 11, 2023
6
September 15, 2016
September 11, 2023
6
September 15, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(877)339-4228
FDAUDIprogram@terumobct.com
FDAUDIprogram@terumobct.com