Duns Number:938647021
Device Description: CARDIOVAC TUBING
Catalog Number
-
Brand Name
EndoWrist
Version/Model Number
420186
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"
-
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
NAY
Product Code Name
System,surgical,computer controlled instrument
Public Device Record Key
f8d15c59-1947-419f-9d27-cb45c73a67e9
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
October 17, 2016
Package DI Number
30886874115238
Quantity per Package
5
Contains DI Package
10886874115234
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 1 |
2 | A medical device with a moderate to high risk that requires special controls. | 376 |