Duns Number:796083090
Catalog Number
-
Brand Name
A-Oss®
Version/Model Number
AOSN200SV
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 12, 2018
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
K151542
Product Code
NPM
Product Code Name
Bone Grafting Material, Animal Source
Public Device Record Key
0e43d696-c5fe-4407-8d0b-5c65857943a9
Public Version Date
July 06, 2018
Public Version Number
4
DI Record Publish Date
September 30, 2016
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 | 359 |
2 | A medical device with a moderate to high risk that requires special controls. | 1552 |