Duns Number:187129135
Device Description: Kit Contains:(1) GTB14, Alexis Contained Extraction System, 14cm(1) CNGL3, GelPoint Mini Kit Contains:(1) GTB14, Alexis Contained Extraction System, 14cm(1) CNGL3, GelPoint Mini Advanced access platform(3) CFF03, 5x100mm Kii Fios First Entry, Advanced Fixation(1) EB010, Voyant 5mm Fusion Device, 37cm
Catalog Number
-
Brand Name
MIGS KIT 4
Version/Model Number
GK161
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
-
Product Code
GCJ
Product Code Name
Laparoscope, General & Plastic Surgery
Public Device Record Key
e414b1f8-c025-4cc2-87b4-a1dc60c41b4e
Public Version Date
January 09, 2020
Public Version Number
2
DI Record Publish Date
May 09, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
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 |