AccessGUDID - DEVICE: creos xenogain (08809186540711)

GUDID

Device Identifier (DI) Information

Brand Name: creos xenogain
Version or Model: N1111-B
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Nibec Co., Ltd.

Primary DI Number: 08809186540711
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 687796909 *Terms of Use

Device Description: Creos xenogain is a sterile, porous bone mineral matrix produced by the removal of the organic compounds from bovine bone. The creos xenogain contains pure hydroxyapatite derived from bovine bone using a validated the manufacturing process. The large surface area of creos xenogain is effective for the regeneration of new bone around the grafted bone. The creos xenogain has good osteoconductivity to enhance new bone formation.

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?
47968	Dental bone matrix implant, animal-derived	A sterile bioabsorbable device made primarily of animal-derived bone or dentin matrix (e.g., bovine, porcine) implanted into the body to provide osteoconductive bone-tissue scaffolds to replace maxillofacial and/or mandibular bone lost through trauma or dental surgery. It is used to fill bone cavities and defects and contains pores that promote the ingrowth of endogenous bone for skeletal reconstruction and/or augmentation. It is typically provided as sterile cancellous blocks, chips, or granules of varying sizes, or mouldable materials.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
NPM	Bone Grafting Material, Animal Source

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K113246	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: between 15 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Weight: .25 Gram

Device Record Status

Public Device Record Key: f849fe12-2e63-4134-8feb-995bbdc484c4
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 23, 2016