Duns Number:063519193
Device Description: Total Vein Systems Ultrasound Probe Cover Natural Polyurethane 6in x 48in 100 per Case
Catalog Number
-
Brand Name
Total Vein Systems
Version/Model Number
26934
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
IYO
Product Code Name
System, imaging, pulsed echo, ultrasonic
Public Device Record Key
fb685748-312b-4395-abfe-63520e6b7aa2
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
October 12, 2016
Package DI Number
00618125140893
Quantity per Package
100
Contains DI Package
01618125140892
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 222 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2255 |