Duns Number:038000253
Device Description: ASH TUNNELERASH TUNNELER
Catalog Number
DAST
Brand Name
NANA
Version/Model Number
DAST
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
-
Product Code
DRC
Product Code Name
Trocar
Public Device Record Key
4e651e3b-290a-4795-b102-fd08fb43f9e9
Public Version Date
August 19, 2019
Public Version Number
1
DI Record Publish Date
August 10, 2019
Package DI Number
50884908145620
Quantity per Package
5
Contains DI Package
00884908145625
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
box
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 31 |
2 | A medical device with a moderate to high risk that requires special controls. | 2560 |