Duns Number:040729840
Device Description: HEARTLINE HEART STABILIZER FINGER ATTACHMENT 2SS-TWO SHORT FINGERS (CAS)
Catalog Number
-
Brand Name
HEART STABILIZER FINGER ATTACHMENT
Version/Model Number
2800-830
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 22, 2018
Issuing Agency
In HIBCC
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
-
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
MWS
Product Code Name
Stabilizer, Heart
Public Device Record Key
cf6c31f3-d3a0-4a8e-b13f-085f220bbcdb
Public Version Date
May 10, 2021
Public Version Number
8
DI Record Publish Date
August 26, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 10108 |
2 | A medical device with a moderate to high risk that requires special controls. | 3414 |