AccessGUDID - DEVICE: Allogran-R® (50601557100448)

GUDID

Device Identifier (DI) Information

Brand Name: Allogran-R®
Version or Model: 800-020
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 800-020
Company Name: BIOCOMPOSITES LTD

Primary DI Number: 50601557100448
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2015
Device Count: 1
Labeler D-U-N-S® Number*: 424382307 *Terms of Use

Device Description: Allogran-R® Tri-Calcium Phosphate Bone Graft Substitute is provided sterile for single patient use. The biodegradable, radiopaque granules/blocks are resorbed in approximately 6-12 months when used in accordance with the device labelling. Biocomposites Tri-Calcium Phosphate Bone Graft Substitute is manufactured from medical grade Tri-Calcium Phosphate. Numerous bone graft operations are undertaken every year to repair bone defects caused by surgery, tumours, trauma, infections and other damage. Allogran-R® Tri-Calcium Phosphate Bone Graft Substitute is intended for use in clinical situations where the use of autologous grafts or other bone graft substitutes maybe undesirable, due either to the risk of associated infection or unavailability. Allogran-R® resorbs and is replaced with bone during the healing process.

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 [?]
K061311	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 39 and 113 Degrees Fahrenheit
Storage Environment Temperature: between 4 and 45 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 20cc

Device Record Status

Public Device Record Key: 79aa46b8-6ae2-4b64-a21a-99b35babf50a
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: April 01, 2015