AccessGUDID - DEVICE: Genex® (50601557114230)

GUDID

Device Identifier (DI) Information

Brand Name: Genex®
Version or Model: Genex® Bone Graft Substitute 10cc
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 910-010
Company Name: BIOCOMPOSITES LTD

Primary DI Number: 50601557114230
Issuing Agency: GS1
Commercial Distribution End Date: January 02, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 424382307 *Terms of Use

Device Description: Genex® Bone Graft Substitute is a simple to use synthetic resorbable material designed to promote regeneration of bone in osseous defects. It degrades into component elements normally found in the body and is highly biocompatible. The kit contains a powder and mixing solution which, when combined, provides a mouldable cohesive paste for introduction into a syringe. When injected the mixture sets to form Genex® Bone Graft Substitute a hard but resorbable matrix. Genex® Bone Graft Substitute is supplied sterile.

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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?
16966	Synthetic bone graft	An artificial bone substitute used for structural bone replacement typically when bone is lost due to disease (e.g., osteoporosis) or injury. It consists mainly of porous and mesh ceramic materials that provide a framework for bone growth, or harvested sea coral that serves as an additive, extender, or provides a framework for bone growth. This is a single-use device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MQV	Filler, Bone Void, Calcium Compound

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: Keep away from sunlight
Special Storage Condition, Specify: Keep dry
Storage Environment Temperature: between 39 and 113 Degrees Fahrenheit
Storage Environment Temperature: between 4 and 45 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 10cc

Device Record Status

Public Device Record Key: 4966ab3a-0749-4ba1-97e4-328d5812c55f
Public Version Date: October 28, 2020
Public Version Number: 2
DI Record Publish Date: March 25, 2019