Duns Number:058614483
Device Description: Fascial Closure System Bladed Trocar with Fixation Cannula Standard
Catalog Number
-
Brand Name
VersaOne
Version/Model Number
B12STFCS
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
K151548,K151548
Product Code
GCJ
Product Code Name
Laparoscope, general & plastic surgery
Public Device Record Key
9ba3a9c3-a4d7-4b84-b0c4-58eaaa397cfb
Public Version Date
March 02, 2021
Public Version Number
3
DI Record Publish Date
April 13, 2018
Package DI Number
20884521678726
Quantity per Package
6
Contains DI Package
10884521678729
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 |