Duns Number:038000253
Device Description: 2F (0.7MM ID) X 2CM2F (0.7MM ID) TEARAWAY INTRODUCER SETTEARAWAY W/40CM NITINOL WIRE & 24G 2F (0.7MM ID) X 2CM2F (0.7MM ID) TEARAWAY INTRODUCER SETTEARAWAY W/40CM NITINOL WIRE & 24GA SAFETY NEEDLESAFETY NEEDLE
Catalog Number
DMR1902424S
Brand Name
VASCU-SHEATH®
Version/Model Number
DMR1902424S
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
DYB
Product Code Name
INTRODUCER, CATHETER
Public Device Record Key
ece41a56-cb8a-444d-bb74-05032992da8e
Public Version Date
August 15, 2019
Public Version Number
1
DI Record Publish Date
August 07, 2019
Package DI Number
30884908144377
Quantity per Package
10
Contains DI Package
00884908144376
Package Discontinue Date
-
Package Status
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 |