Duns Number:187129135
Device Description: Access platform for minimally invasive surgery
Catalog Number
-
Brand Name
GelPOINT® Mini Advanced Access Platform
Version/Model Number
CNGL3
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"
Yes
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
5db119cf-5fb6-4418-b158-37e2856e876f
Public Version Date
November 06, 2020
Public Version Number
3
DI Record Publish Date
March 25, 2016
Package DI Number
10607915127944
Quantity per Package
1
Contains DI Package
00607915131784
Package Discontinue Date
January 16, 2016
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 |