Duns Number:071595540
Device Description: 28.6 mm Disposable Bipolar Cord, 12 ft. (3.6 m)
Catalog Number
60-6102-002
Brand Name
NA
Version/Model Number
60-6102-002
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
K831236,K831236,K831236
Product Code
GEI
Product Code Name
Electrosurgical, cutting & coagulation & accessories
Public Device Record Key
b1aada58-205a-450b-906c-cdf094c5a789
Public Version Date
February 04, 2020
Public Version Number
1
DI Record Publish Date
January 27, 2020
Package DI Number
20845854051433
Quantity per Package
10
Contains DI Package
10845854051436
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 |