DEVICE: ReBOSSIS (04573190050231)

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Device Identifier (DI) Information

ReBOSSIS
0.7g
ITS-0207B
ORTHOREBIRTH CO.,LTD.
04573190050231
GS1
1
ReBOSSIS is a cotton-like synthetic, resorbable bone void filler. It is composite material consisting of beta-tricalcium phosphate, siloxane-containing vaterite (a form of calcium carbonate), and poly(L-lactide). The electrospinning process used in manufacturing ReBOSSIS results in a cotton-like physical form. Due to its physical form, ReBOSSIS is flexible and can easily fill defects in appropriate amounts.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Synthetic bone graft An artificial bone substitute used for structural bone replacement typically when bone is lost due to disease (e.g., osteoporosis) or injury. It consists mainly of porous and mesh ceramic materials that provide a framework for bone growth, or harvested sea coral that serves as an additive, extender, or provides a framework for bone growth. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
MQV Filler, Bone Void, Calcium Compound
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Storage Environment Temperature: less than 25 Degrees Celsius
Special Storage Condition, Specify: Store in a dry place
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Clinically Relevant Size

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Size Type Text
Total Volume: 18 Milliliter
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Device Status

Not in Commercial Distribution
September 24, 2015
August 01, 2017
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

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866-426-2323
dblake@orthorebirthusa.com
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