Duns Number:058614483
Device Description: Fascial Closure System Optical Trocar with Fixation Cannula, Standard
Catalog Number
-
Brand Name
VersaOne
Version/Model Number
ONB12STFCS
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
K163654,K163654
Product Code
GCJ
Product Code Name
Laparoscope, general & plastic surgery
Public Device Record Key
ef730859-5018-4269-83a5-3c0ef0e46987
Public Version Date
August 24, 2022
Public Version Number
4
DI Record Publish Date
August 25, 2018
Package DI Number
20884521678719
Quantity per Package
6
Contains DI Package
10884521678712
Package Discontinue Date
-
Package Status
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 |