AccessGUDID - DEVICE: Unigraft (D767U0101051)

GUDID

Device Identifier (DI) Information

Brand Name: Unigraft
Version or Model: 200-400um 0.4g
Commercial Distribution Status: In Commercial Distribution
Catalog Number: U01-0105
Company Name: UNICARE BIOMEDICAL INC.

Primary DI Number: D767U0101051
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 5
Labeler D-U-N-S® Number*: 038023573 *Terms of Use

Device Description: Unigraft is made of synthetic bioactive glass material. The product is conveniently packaged in a sterile vial and stored within a hermetically sealed foil pouch to ensure product sterility prior to implantation. Unigraft offers an osteogenic framework for new bone growth and bolsters a higher level of osteoblastic activity to enhance bone regeneration. FDA has cleared this product for use in treating periodontal defects, extractions sites, sinus elevation, apicoectomy and root resection, cranial and facial augmentation and augmentation of the alveolar ridges.

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
LYC	Bone Grafting Material, Synthetic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K092567	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 30 Degrees Celsius
Storage Environment Humidity: between 0 and 65 Percent (%) Relative Humidity
Special Storage Condition, Specify: Store in a dry, well ventilated environment. Keep out of sunlight.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 9569fca7-8280-4c46-9620-37289f90ec6b
Public Version Date: July 27, 2021
Public Version Number: 4
DI Record Publish Date: September 18, 2015