Duns Number:058614483
Device Description: Fixation Cannula
Catalog Number
-
Brand Name
Versaport
Version/Model Number
177093F
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 22, 2022
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
K062326,K062326
Product Code
GCJ
Product Code Name
Laparoscope, general & plastic surgery
Public Device Record Key
aafb470b-00ba-49c4-a393-917a8fbdfe3c
Public Version Date
September 14, 2022
Public Version Number
6
DI Record Publish Date
September 24, 2016
Package DI Number
10884521094437
Quantity per Package
3
Contains DI Package
20884521094434
Package Discontinue Date
April 22, 2022
Package Status
Not 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 |