Duns Number:532199478
Catalog Number
560-6638
Brand Name
Power Cord for VS3 Cart - Argentina
Version/Model Number
VS3
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K183453
Product Code
GCJ
Product Code Name
Laparoscope, General & Plastic Surgery
Public Device Record Key
a5b93f75-eba1-4c61-893d-d2daa59902af
Public Version Date
December 03, 2019
Public Version Number
1
DI Record Publish Date
November 25, 2019
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 | 5 |
2 | A medical device with a moderate to high risk that requires special controls. | 77 |