DEVICE: Trabexus® (W4146EB0010T0475)
Device Identifier (DI) Information
Trabexus®
10 cc
In Commercial Distribution
130703-10
Vivorte, Inc
10 cc
In Commercial Distribution
130703-10
Vivorte, Inc
Calcium compound bone void filler with DBM (10 cc), previously sold under Trabexus® EB brand name.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No | |
Yes | |
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Yes |
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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61884 | Cadaveric-donor/synthetic mineral bone graft |
A sterile implantable device consisting of demineralized bone matrix (DBM) processed from cadaveric human bone (allograft) and mixed with bioabsorbable synthetic minerals (e.g., calcium phosphate), intended to fill bony voids or gaps in the skeletal system (e.g., spine, pelvis, extremities) that have been surgically or traumatically created; it may also serve as a bone graft extender. It is designed to be resorbed/remodelled and replaced by host bone during the healing process. It is typically supplied as a kit which requires mixing to form a putty-like substance prior to implantation.
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Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MQV | Filler, Bone Void, Calcium Compound |
MBP | Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) |
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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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
b5ebd4be-0485-4cc2-9cb3-5d40a992d810
July 30, 2021
3
January 28, 2016
July 30, 2021
3
January 28, 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
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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