DEVICE: Vertecem II Cement Kit (04260056880759)

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Device Identifier (DI) Information

Vertecem II Cement Kit
08.702.017S
08.702.017S
aap Biomaterials GmbH
04260056880759
GS1
1
Vertecem II is a radio-opaque, injectable acrylic bone cement used for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using a Vertebroplasty or Kyphoplasty procedure.
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Device Characteristics

Labeling does not contain MRI Safety Information
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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
LOD Bone Cement
NDN Cement, Bone, Vertebroplasty
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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
Special Storage Condition, Specify: Store between 0°C (32°F) and 26°C (77°F)
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Clinically Relevant Size

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Size Type Text
Weight: 22 Gram
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Device Status

In Commercial Distribution
October 21, 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
14260056880756 21 04260056880759 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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Yes
No
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No CLOSE

Customer Contact

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No Customer Contact currently defined
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