Duns Number:187129135
Device Description: Kit Includes:GTB14, ALEXIS CONTAINED EXTRACTION SYSTEMC0R47, 12x100 Kii BALLOON BLUNT TIP Kit Includes:GTB14, ALEXIS CONTAINED EXTRACTION SYSTEMC0R47, 12x100 Kii BALLOON BLUNT TIP TROCAR
Catalog Number
-
Brand Name
Alexis Contained Extraction System with Kii Balloon Blunt Tip System
Version/Model Number
GTK14
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
e0513f88-e99c-4f13-89ed-8282d087ad25
Public Version Date
January 09, 2020
Public Version Number
3
DI Record Publish Date
September 24, 2016
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 |