Duns Number:058614483
Device Description: Bladeless Positioning Trocar System Standard
Catalog Number
-
Brand Name
VersaOne
Version/Model Number
RNONB12STF
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 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
8bdb1369-76ba-49c7-9652-43aa6b28b5b8
Public Version Date
August 08, 2022
Public Version Number
4
DI Record Publish Date
April 25, 2019
Package DI Number
20884521717708
Quantity per Package
6
Contains DI Package
10884521717701
Package Discontinue Date
April 29, 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 |