Duns Number:071595540
Device Description: UNIVERSAL PLUS/FLOVAC, SUMP CANNULA WITHOUT SIDE HOLES, CANNULA 10MM X 32CM
Catalog Number
60-6001-105
Brand Name
UNIVERSAL PLUS/FLOVAC
Version/Model Number
60-6001-105
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 06, 2022
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
K960562,K960562,K960562
Product Code
GCJ
Product Code Name
Laparoscope, general & plastic surgery
Public Device Record Key
7b1d20a5-dbb3-444c-9f53-f36d748f111a
Public Version Date
June 07, 2022
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
20653405011405
Quantity per Package
5
Contains DI Package
30653405011402
Package Discontinue Date
June 06, 2022
Package Status
Not 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 |