Duns Number:038000253
Device Description: 3F (1.0MM ID) X 5CM3F (1.0MM ID) TEARAWAY INTRODUCER SETTEARAWAY W/NITINOL GUIDEWIREW/NITI 3F (1.0MM ID) X 5CM3F (1.0MM ID) TEARAWAY INTRODUCER SETTEARAWAY W/NITINOL GUIDEWIREW/NITINOL GUI W/RADIOPAQUE TIPW/RADIOPAQUE TIP
Catalog Number
DMR190300
Brand Name
VASCU-SHEATH®
Version/Model Number
DMR190300
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
f652cca9-40e7-475a-9cb9-bf2eff3ba1fb
Public Version Date
October 05, 2020
Public Version Number
2
DI Record Publish Date
August 09, 2019
Package DI Number
30884908145428
Quantity per Package
10
Contains DI Package
00884908145427
Package Discontinue Date
July 28, 2020
Package Status
Not in Commercial Distribution
Package Type
inner 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 |