Duns Number:058614483
Device Description: Fascial Closure System Reusable Suture Passer
Catalog Number
-
Brand Name
VersaOne
Version/Model Number
FCSPASS
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
-
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
79b5f8cd-18b3-4e26-ba2b-92df67882648
Public Version Date
April 18, 2022
Public Version Number
8
DI Record Publish Date
September 14, 2017
Package DI Number
20884521678702
Quantity per Package
6
Contains DI Package
10884521678705
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| 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 |