Duns Number:066839630
Device Description: Graft Delivery Device with Custom Cannula
Catalog Number
-
Brand Name
NA
Version/Model Number
LS-1015-150
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"
Yes
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
K151543,K151543,K151543
Product Code
FMF
Product Code Name
Syringe, Piston
Public Device Record Key
601f8334-b55a-41b6-bd76-18c2f2c84a51
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 25, 2016
Package DI Number
10815634020051
Quantity per Package
5
Contains DI Package
00815634020054
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
SHELF BOX
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 35 |
2 | A medical device with a moderate to high risk that requires special controls. | 34 |