Duns Number:071595540
Device Description: UNIVERSAL PLUS MULTIFUNCTION INSTRUMENT SYSTEM (STRAIGHT HANDLE), STRAIGHT HANDLE ELECTROS UNIVERSAL PLUS MULTIFUNCTION INSTRUMENT SYSTEM (STRAIGHT HANDLE), STRAIGHT HANDLE ELECTROSURGICAL SUCTION/IRRIGATION INSTRUMENT WITH FOOT CONTROLLED ELECTROSURGERY AND Y-CONNECTOR SET
Catalog Number
60-6010-021
Brand Name
UNIVERSAL PLUS
Version/Model Number
60-6010-021
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 09, 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
-
Product Code
GCJ
Product Code Name
Laparoscope, general & plastic surgery
Public Device Record Key
2edd62f7-a3dd-4448-beb0-b87dd788011a
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
20653405011757
Quantity per Package
10
Contains DI Package
30653405011754
Package Discontinue Date
June 09, 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 |