Duns Number:007198742
Catalog Number
-
Brand Name
Disposable Bipolar Cord Vista CTR System
Version/Model Number
DBC
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
K022480,K022480
Product Code
HGI
Product Code Name
ELECTROCAUTERY, GYNECOLOGIC (AND ACCESSORIES)
Public Device Record Key
c804f38f-8088-451d-adaf-57505fb382f1
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 05, 2016
Package DI Number
00821925010659
Quantity per Package
12
Contains DI Package
00821925041752
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 | 899 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1586 |
| 3 | A medical device with high risk that requires premarket approval | 9 |
| U | Unclassified | 4 |