Duns Number:071595540
Device Description: UNIVERSAL PLUS LAPAROSCOPIC ELECTRODE WITH SUCTION/IRRIGATION, 5MM X 32CM L-HOOK
Catalog Number
60-5272-132
Brand Name
UNIVERSAL PLUS
Version/Model Number
60-5272-132
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
K942892,K942892,K942892
Product Code
GEI
Product Code Name
ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
Public Device Record Key
298773ee-6ca8-4a8f-8ee8-9f50c8d9db53
Public Version Date
February 07, 2019
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
20653405010620
Quantity per Package
5
Contains DI Package
30653405010627
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 |