Duns Number:038000253
Device Description: 3F (1.1MM ID) X 3CM3F (1.1MM ID) TEARAWAY INTRODUCER SETTEARAWAY W/60CM STEEL WIRE & 24GA 3F (1.1MM ID) X 3CM3F (1.1MM ID) TEARAWAY INTRODUCER SETTEARAWAY W/60CM STEEL WIRE & 24GA SAFETY NEEDLESAFETY NEEDLE
Catalog Number
DMR1903624S
Brand Name
VASCU-SHEATH®
Version/Model Number
DMR1903624S
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
55884e81-2529-43d2-a379-310d50cac965
Public Version Date
September 12, 2019
Public Version Number
1
DI Record Publish Date
September 04, 2019
Package DI Number
50884908144630
Quantity per Package
4
Contains DI Package
30884908144636
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 |