Duns Number:071595540
Device Description: UNIVERSAL PLUS, SUMP CANNULA WITH SIDE HOLES, STAINLESS STEEL REUSABLE CANNULA 10MM X 44CM
Catalog Number
60-6002-308
Brand Name
UNIVERSAL PLUS
Version/Model Number
60-6002-308
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
K960562,K960562
Product Code
GCJ
Product Code Name
Laparoscope, general & plastic surgery
Public Device Record Key
bd3ddebc-053d-4747-a2ca-b3dbd05de314
Public Version Date
July 06, 2018
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 | 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 |