Duns Number:255276362
Device Description: The Cor-Valv Cable is intended to be used with the corresponding CORONEO Cor-Valv system r The Cor-Valv Cable is intended to be used with the corresponding CORONEO Cor-Valv system retractor for retraction of heart tissue during cardiac surgery. This product is provided sterile in a sealed package, and consists one(1) cable that is single-use and disposable held by a plastic insert.
Catalog Number
1011180
Brand Name
Cor-Valv Atrial Retractor Cables with Fitting
Version/Model Number
1011180
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
GAD
Product Code Name
Retractor
Public Device Record Key
28ece483-476d-4dfb-994a-550ed06bb06c
Public Version Date
October 06, 2022
Public Version Number
1
DI Record Publish Date
September 28, 2022
Package DI Number
10817121000195
Quantity per Package
10
Contains DI Package
00817121000198
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 | 9 |