Duns Number:001191048
Device Description: Monopolar High Frequency Cord Male to Female Connector
Catalog Number
5601100
Brand Name
Monopolar High Frequency Cord Male to Female Connector
Version/Model Number
5601100
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 31, 2017
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
-
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
K911274,K911274
Product Code
GEI
Product Code Name
ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
Public Device Record Key
ec101fd8-38db-4e96-88cb-b905e9b05423
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
February 22, 2016
Package DI Number
10801741077286
Quantity per Package
1
Contains DI Package
00801741077289
Package Discontinue Date
May 31, 2017
Package Status
Not in Commercial Distribution
Package Type
Other
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 8 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 348 |
| 3 | A medical device with high risk that requires premarket approval | 18 |