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: aap Biomaterials 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 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.

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

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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.

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.

FDA Product Code

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Product Code	Product Code Name
NDN	Cement, Bone, Vertebroplasty
LOD	Bone Cement

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

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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

Clinically Relevant Size

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Size Type Text
Weight: 24 Gram

Device Record Status

Public Device Record Key: 99513783-9a2c-4618-8ccd-728c4c70927d
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: October 02, 2015