Duns Number:423459374
Device Description: ReproBone synthetic bone graft substitute, Granules (0.5-1.0mm), 2.0cc
Catalog Number
-
Brand Name
ReproBone
Version/Model Number
RBD2
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 20, 2021
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
K103820
Product Code
LYC
Product Code Name
Bone Grafting Material, Synthetic
Public Device Record Key
95db763d-4e35-4ae4-9cb3-3b1975a28a55
Public Version Date
October 21, 2021
Public Version Number
4
DI Record Publish Date
July 31, 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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 32 |