Duns Number:071595540
Device Description: UNIVERSAL PLUS MULTIFUNCTION INSTRUMENT SYSTEM (PISTOL GRIP HANDLE), ELECTROSURGICAL SUCTI UNIVERSAL PLUS MULTIFUNCTION INSTRUMENT SYSTEM (PISTOL GRIP HANDLE), ELECTROSURGICAL SUCTION/IRRIGATION INSTRUMENT WITH HAND CONTROLLED ELECTROSURGERY
Catalog Number
60-6010-002
Brand Name
UNIVERSAL PLUS
Version/Model Number
60-6010-002
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
-
Product Code
GEI
Product Code Name
Electrosurgical, cutting & coagulation & accessories
Public Device Record Key
bd78b927-1a52-4cd8-bd04-6360c5e62419
Public Version Date
May 31, 2021
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
20653405011702
Quantity per Package
10
Contains DI Package
30653405011709
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 |