Duns Number:023055619
Device Description: Large (blue) for grafts up to 10 mm, 20 1/2" / 52 cm (1/pkg)
Catalog Number
9009-16
Brand Name
SCANLAN® Vascular Tunneler Sheaths and Bullet Tips
Version/Model Number
9009-16
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
-
Product Code
DWS
Product Code Name
Instruments, Surgical, Cardiovascular
Public Device Record Key
d73f7c76-cc90-4fea-99f4-9f1eeea710b1
Public Version Date
November 25, 2020
Public Version Number
1
DI Record Publish Date
November 17, 2020
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 | 1949 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 855 |