Duns Number:187129135
Device Description: Trocar
Catalog Number
-
Brand Name
Optical Non-Bladed System
Version/Model Number
EJ067P
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 22, 2019
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
-
Product Code
GCJ
Product Code Name
Laparoscope, General & Plastic Surgery
Public Device Record Key
49a84123-217f-4ead-b839-6ac027b5e071
Public Version Date
January 09, 2020
Public Version Number
4
DI Record Publish Date
August 22, 2016
Package DI Number
40386534279708
Quantity per Package
6
Contains DI Package
40386534279630
Package Discontinue Date
July 22, 2019
Package Status
Not in Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 499 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 698 |
| 3 | A medical device with high risk that requires premarket approval | 1 |