Duns Number:001191048
Device Description: Quick-Disconnect Endo-Pool Suction Cannula Probe Tip Size: 10mm/33cm
Catalog Number
5105950
Brand Name
Quick Disconnect Endo-Pool
Version/Model Number
5105950
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
-
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
K913999
Product Code
GCJ
Product Code Name
Laparoscope, general & plastic surgery
Public Device Record Key
8765334c-ee44-4b44-83db-2fe781eacb86
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
April 29, 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 | 8 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 348 |
| 3 | A medical device with high risk that requires premarket approval | 18 |