DEVICE: BioHorizons (00847236015817)
Device Identifier (DI) Information
BioHorizons
IS110Z
In Commercial Distribution
BIOHORIZONS IMPLANT SYSTEMS, INC
IS110Z
In Commercial Distribution
BIOHORIZONS IMPLANT SYSTEMS, INC
IntraSpin Centrifuge, 110 volts
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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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47183 | Haematological concentrate system |
An assembly of devices typically used at the point-of-care to concentrate platelets or bone marrow aspirate cells, through low-speed centrifugal force (e.g., 2,500 to 7,000 rpm), from a small volume of a patient's own blood/bone marrow for the rapid preparation of platelet-rich plasma (PRP) or bone marrow aspirate concentrate (BMAC). It typically consists of a centrifuge, a dedicated centrifuge tube(s) and sample collection/processing kits, a concentrate delivery unit, and various disposable applicators. After processing, 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.
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FDA Product Code
[?]Product Code | Product Code Name |
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ORG | Platelet And Plasma Separator For Bone Graft Handling |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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BK120048 | 0 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
7e9afb86-8170-4b3d-b084-89df312e8ccb
October 15, 2020
1
October 07, 2020
October 15, 2020
1
October 07, 2020
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
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined