AccessGUDID - DEVICE: BonOs Inject (04260056883231)

GUDID

Device Identifier (DI) Information

Brand Name: BonOs Inject
Version or Model: 01-0309
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: OSARTIS GmbH

Primary DI Number: 04260056883231
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 344261631 *Terms of Use

Device Description: BonOs® Inject is a radiopaque, injectable bone cement for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using vertebroplasty or balloon kyphoplasty procedure. When used in conjunction with NEO Pedicle Screw System™ BonOs® Inject is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. NEO Pedicle Screws augmented with BonOs® Inject Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised. 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
60505	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 may be a sterile powder of a synthetic polymer [e.g., polymethylmethacrylate (PMMA)] that is mixed with its sterile diluent, or a non-PMMA-containing elastomer formed by mixing two precursors, prior to implantation typically during a balloon kyphoplasty or vertebroplasty procedure. This device does not contain an antibiotic agent. After application, this device cannot be reused.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
NDN	Cement, Bone, Vertebroplasty
LOD	Bone Cement
NKD	Stimulator, Spinal Cord, Implanted For Female Sexual Dysfunction
PML	Bone Cement, Posterior Screw Augmentation

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

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

Clinically Relevant Size

[?]

Size Type Text
Weight: 24 Gram

Device Record Status

Public Device Record Key: 99513783-9a2c-4618-8ccd-728c4c70927d
Public Version Date: June 12, 2023
Public Version Number: 5
DI Record Publish Date: October 02, 2015