Duns Number:004095409
Device Description: Graftgun Universal Graft Delivery System labeled with a different catalog for Integrity Im Graftgun Universal Graft Delivery System labeled with a different catalog for Integrity Implants to distribute.
Catalog Number
-
Brand Name
Graftgun Universal Graft Delivery System
Version/Model Number
IG-U-1000
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
K170675
Product Code
FMF
Product Code Name
Syringe, Piston
Public Device Record Key
093f55e9-58b8-4fbb-b3aa-3dca64b217d2
Public Version Date
December 05, 2019
Public Version Number
1
DI Record Publish Date
November 27, 2019
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 | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 24 |
| U | Unclassified | 15 |