Duns Number:687429456
Catalog Number
-
Brand Name
THE Graft
Version/Model Number
TG-B50
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K173188
Product Code
NPM
Product Code Name
Bone Grafting Material, Animal Source
Public Device Record Key
63675ed7-95eb-4d5c-817f-8f8b903f25d8
Public Version Date
November 15, 2018
Public Version Number
1
DI Record Publish Date
October 15, 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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 64 |