Duns Number:038000253
Device Description: 6.5F (2.0MM ID) X 10CM6.5F (2.0M TEARAWAY INTRODUCER SETTEARAWAY W/NITINOL GUIDEWIREW/NITI 6.5F (2.0MM ID) X 10CM6.5F (2.0M TEARAWAY INTRODUCER SETTEARAWAY W/NITINOL GUIDEWIREW/NITINOL GUI W/RADIOPAQUE TIPW/RADIOPAQUE TIP
Catalog Number
DMR190610
Brand Name
SUPER SHEATH 2.0SUPER SHEATH 2.0
Version/Model Number
DMR190610
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 28, 2020
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
DYB
Product Code Name
INTRODUCER, CATHETER
Public Device Record Key
bdb54df3-33d5-4540-8a4c-6e9956fc0048
Public Version Date
October 05, 2020
Public Version Number
2
DI Record Publish Date
September 04, 2019
Package DI Number
50884908144647
Quantity per Package
4
Contains DI Package
30884908144643
Package Discontinue Date
July 28, 2020
Package Status
Not 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 |