Duns Number:071595540
Device Description: Bladeless Mini Trocar
Catalog Number
G3-M05S-NB
Brand Name
ENTRIPORT
Version/Model Number
G3-M05S-NB
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
K142464,K142464,K142464
Product Code
GCJ
Product Code Name
Laparoscope, general & plastic surgery
Public Device Record Key
41dec6ea-e6cb-4a33-9397-96af61e8b335
Public Version Date
January 09, 2020
Public Version Number
4
DI Record Publish Date
March 08, 2017
Package DI Number
20653405081897
Quantity per Package
10
Contains DI Package
10653405081890
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1412 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2261 |
| 3 | A medical device with high risk that requires premarket approval | 95 |