Duns Number:071595540
Device Description: UNIVERSAL PLUS LAPAROSCOPIC ELECTRODE WITH ESCHAR-RESISTANT COATING - SUCTION/IRRIGATION, UNIVERSAL PLUS LAPAROSCOPIC ELECTRODE WITH ESCHAR-RESISTANT COATING - SUCTION/IRRIGATION, 5MM X 32CM NEEDLE
Catalog Number
60-5274-932
Brand Name
UNIVERSAL PLUS
Version/Model Number
60-5274-932
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
K952204,K952204,K952204
Product Code
GEI
Product Code Name
ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
Public Device Record Key
953e41f1-8582-42d4-a6f1-540121f763b8
Public Version Date
February 07, 2019
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
20653405010828
Quantity per Package
5
Contains DI Package
30653405010825
Package Discontinue Date
-
Package Status
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 |