Duns Number:196548481
Device Description: Bipolar Irrigator Integrated Tubing and Bipolar Cord Set, Disposable, Unitized Plug
Catalog Number
6790-100-004
Brand Name
N/A
Version/Model Number
6790-100-004
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
9fdf1ef9-891c-4f8b-9bf2-c579da75d396
Public Version Date
April 23, 2019
Public Version Number
5
DI Record Publish Date
January 03, 2017
Package DI Number
37613327304207
Quantity per Package
10
Contains DI Package
07613327304206
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
pack
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2188 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3183 |
| U | Unclassified | 60 |