Duns Number:038000253
Device Description: 2F (0.7MM ID) X 2CM2F (0.7MM ID) TEARAWAY INTRODUCER SETTEARAWAY W/20CM NITINOL WIRE & 22G 2F (0.7MM ID) X 2CM2F (0.7MM ID) TEARAWAY INTRODUCER SETTEARAWAY W/20CM NITINOL WIRE & 22GA SAFETY NEEDLESAFETY NEEDLE
Catalog Number
DMR1902222S
Brand Name
VASCU-SHEATH®
Version/Model Number
DMR1902222S
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
a56d0204-54c1-49a9-9017-996ec54fa7a3
Public Version Date
August 15, 2019
Public Version Number
1
DI Record Publish Date
August 07, 2019
Package DI Number
50884908144333
Quantity per Package
4
Contains DI Package
30884908144339
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 |