Duns Number:058614483
Device Description: Fascial Closure System Bladeless Trocar with Fixation Cannula Standard
Catalog Number
-
Brand Name
VersaOne
Version/Model Number
NONB12STFCS
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 29, 2021
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
K151548,K151548
Product Code
GCJ
Product Code Name
Laparoscope, general & plastic surgery
Public Device Record Key
ed65456e-b9d6-4f59-bea7-952bfb8ca849
Public Version Date
September 08, 2022
Public Version Number
4
DI Record Publish Date
April 13, 2018
Package DI Number
20884521678733
Quantity per Package
6
Contains DI Package
10884521678736
Package Discontinue Date
January 21, 2021
Package Status
Not in Commercial Distribution
Package Type
PACK_OR_INNER_PACK
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 132 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8540 |
| 3 | A medical device with high risk that requires premarket approval | 202 |
| U | Unclassified | 40 |