DEVICE: BonOs Inject (04260056883231)

Device Identifier (DI) Information

BonOs Inject
01-0309
In Commercial Distribution

aap Biomaterials GmbH
04260056883231
GS1

1
344261631 *Terms of Use
BonOs® Inject is a radiopaque, injectable bone cement for use in spine surgery like percutaneous vertebral augmentation during vertebroplasty or kyphoplasty. Mixing the two separate sterile components initially produces a ductile, injectable bone cement which, after hardening in situ, is able to stabilize neoplastic vertebral lesions and vertebral compression fractures. BonOs® Inject cement powder also contains insoluble zirconium dioxide as an X-ray contrast medium.
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Device Characteristics

Labeling does not contain MRI Safety Information
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No
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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
Vertebral bone filler, non-bioabsorbable A sterile substance intended to be used to replace cortical/cancellous bone in a vertebral body to stabilize vertebral compression fractures (VCFs) caused by cancer, osteoporosis, or trauma. The device is typically a sterile powder of a synthetic polymer [e.g., polymethylmethacrylate (PMMA)], that is mixed with its sterile diluent prior to implantation, and designed to be implanted during a balloon kyphoplasty or vertebroplasty procedure. This device does not contain an antibiotic agent. After application, this device cannot be reused.
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FDA Product Code

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Product Code Product Code Name
NDN Cement, Bone, Vertebroplasty
LOD Bone Cement
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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Sterilization

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

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Storage and Handling
Special Storage Condition, Specify: Store between 0°C (32°F) and 25°C (77°F)
Handling Environment Temperature: between 18 and 25 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
Weight: 24 Gram
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Device Record Status

99513783-9a2c-4618-8ccd-728c4c70927d
March 29, 2018
2
October 02, 2015
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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
14260056883238 20 04260056883231 In Commercial Distribution Shipping unit
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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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Customer Contact

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No Customer Contact currently defined
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