Duns Number:113344790
Device Description: 2.0cc AlloSculpt Demineralized Cortical Putty
Catalog Number
-
Brand Name
ALLO-2.0
Version/Model Number
Rev A
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K103699
Product Code
NUN
Product Code Name
Bone Grafting Material, Human Source
Public Device Record Key
04d00cf4-c228-4d53-b544-f981b8c1b867
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
February 22, 2018
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 | 8 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 53 |
| 3 | A medical device with high risk that requires premarket approval | 3 |