Vertecem II Cement Kit 08.702.017S

GUDID 04260056880759

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.

OSARTIS GmbH

Vertebral bone filler, non-bioabsorbable Vertebral bone filler, non-bioabsorbable Vertebral bone filler, non-bioabsorbable Vertebral bone filler, non-bioabsorbable Vertebral bone filler, non-bioabsorbable Vertebral bone filler, non-bioabsorbable Vertebral bone filler, non-bioabsorbable Vertebral bone filler, non-bioabsorbable Vertebral bone filler, non-bioabsorbable Vertebral bone filler, non-bioabsorbable Vertebral bone filler, non-bioabsorbable Vertebral bone filler, non-bioabsorbable Vertebral bone filler, non-bioabsorbable

• Primary Device ID: 04260056880759
• NIH Device Record Key: c39685df-bd2f-4d59-a0b8-a22319c3f060
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vertecem II Cement Kit
• Version Model Number: 08.702.017S
• Catalog Number: 08.702.017S
• Company DUNS: 344261631
• Company Name: OSARTIS GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Weight: 22 Gram
• Weight: 22 Gram
• Weight: 22 Gram
• Weight: 22 Gram
• Weight: 22 Gram
• Weight: 22 Gram
• Weight: 22 Gram
• Weight: 22 Gram
• Weight: 22 Gram
• Weight: 22 Gram
• Weight: 22 Gram
• Weight: 22 Gram
• Weight: 22 Gram

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store between 0°C (32°F) and 26°C (77°F)
• Special Storage Condition, Specify: Between 0 and 0 *Store between 0°C (32°F) and 26°C (77°F)
• Special Storage Condition, Specify: Between 0 and 0 *Store between 0°C (32°F) and 26°C (77°F)
• Special Storage Condition, Specify: Between 0 and 0 *Store between 0°C (32°F) and 26°C (77°F)
• Special Storage Condition, Specify: Between 0 and 0 *Store between 0°C (32°F) and 26°C (77°F)
• Special Storage Condition, Specify: Between 0 and 0 *Store between 0°C (32°F) and 26°C (77°F)
• Special Storage Condition, Specify: Between 0 and 0 *Store between 0°C (32°F) and 26°C (77°F)
• Special Storage Condition, Specify: Between 0 and 0 *Store between 0°C (32°F) and 26°C (77°F)
• Special Storage Condition, Specify: Between 0 and 0 *Store between 0°C (32°F) and 26°C (77°F)
• Special Storage Condition, Specify: Between 0 and 0 *Store between 0°C (32°F) and 26°C (77°F)
• Special Storage Condition, Specify: Between 0 and 0 *Store between 0°C (32°F) and 26°C (77°F)
• Special Storage Condition, Specify: Between 0 and 0 *Store between 0°C (32°F) and 26°C (77°F)
• Special Storage Condition, Specify: Between 0 and 0 *Store between 0°C (32°F) and 26°C (77°F)

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260056880759 [Primary]
GS1	14260056880756 [Package]; Package: Shipping unit [21 Units]; In Commercial Distribution

FDA Product Code

• NDN: Cement, Bone, Vertebroplasty

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-14
• Device Publish Date: 2015-10-21

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