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
Primary Device ID04260056880759
NIH Device Record Keyc39685df-bd2f-4d59-a0b8-a22319c3f060
Commercial Distribution StatusIn Commercial Distribution
Brand NameVertecem II Cement Kit
Version Model Number08.702.017S
Catalog Number08.702.017S
Company DUNS344261631
Company NameOSARTIS GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Weight22 Gram
Weight22 Gram
Weight22 Gram
Weight22 Gram
Weight22 Gram
Weight22 Gram
Weight22 Gram
Weight22 Gram
Weight22 Gram
Weight22 Gram
Weight22 Gram
Weight22 Gram
Weight22 Gram

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store between 0°C (32°F) and 26°C (77°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Store between 0°C (32°F) and 26°C (77°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Store between 0°C (32°F) and 26°C (77°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Store between 0°C (32°F) and 26°C (77°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Store between 0°C (32°F) and 26°C (77°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Store between 0°C (32°F) and 26°C (77°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Store between 0°C (32°F) and 26°C (77°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Store between 0°C (32°F) and 26°C (77°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Store between 0°C (32°F) and 26°C (77°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Store between 0°C (32°F) and 26°C (77°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Store between 0°C (32°F) and 26°C (77°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Store between 0°C (32°F) and 26°C (77°F)
Special Storage Condition, SpecifyBetween 0 and 0 *Store between 0°C (32°F) and 26°C (77°F)

Device Identifiers

Device Issuing AgencyDevice ID
GS104260056880759 [Primary]
GS114260056880756 [Package]
Package: Shipping unit [21 Units]
In Commercial Distribution

FDA Product Code

NDNCement, Bone, Vertebroplasty

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-02-14
Device Publish Date2015-10-21

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