Duns Number:424382307
Device Description: Allogran-R® Tri-Calcium Phosphate Bone Graft Substitute is provided sterile for single pat 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.
Catalog Number
800-005
Brand Name
Allogran-R®
Version/Model Number
800-005
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 02, 2020
Issuing Agency
In GS1
MRI safety Status
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)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K061311
Product Code
MQV
Product Code Name
Filler, Bone Void, Calcium Compound
Public Device Record Key
3fa05118-e79e-4253-9042-b85d5c3b4809
Public Version Date
November 02, 2020
Public Version Number
4
DI Record Publish Date
April 01, 2015
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 89 |