Duns Number:058614483
Device Description: Bladeless Positioning Trocar System Long
Catalog Number
-
Brand Name
VersaOne
Version/Model Number
RNONB8LGF
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
K162584,K162584
Product Code
GCJ
Product Code Name
Laparoscope, general & plastic surgery
Public Device Record Key
d3126f95-6543-4793-b83b-540e2f16a1da
Public Version Date
August 08, 2022
Public Version Number
5
DI Record Publish Date
May 03, 2018
Package DI Number
20884521717654
Quantity per Package
6
Contains DI Package
10884521717657
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 |