AccessGUDID - DEVICE: ReBOSSIS (04573190050125)

GUDID

Device Identifier (DI) Information

Brand Name: ReBOSSIS
Version or Model: 1.0g
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: ORB-0110B
Company Name: ORTHOREBIRTH CO.,LTD.

Primary DI Number: 04573190050125
Issuing Agency: GS1
Commercial Distribution End Date: November 11, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 691435666 *Terms of Use

Device Description: ReBOSSIS is a cotton-like synthetic, resorbable bone void filler. It is composite material consisting of beta-tricalcium phosphate, siloxane-containing vaterite (a form of calcium carbonate), and poly(L-lactide). The electrospinning process used in manufacturing ReBOSSIS results in a cotton-like physical form. Due to its physical form, ReBOSSIS is flexible and can easily fill defects in appropriate amounts.

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?
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 [?]
K142090	000

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
Storage Environment Temperature: less than 25 Degrees Celsius
Special Storage Condition, Specify: Store in a dry place

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 25 Milliliter

Device Record Status

Public Device Record Key: 36bb27a5-51cb-4481-9b5f-99d6f6f9fb4d
Public Version Date: November 12, 2018
Public Version Number: 4
DI Record Publish Date: September 24, 2015