Duns Number:790605856
Device Description: Long Upgrade Kit 12-15/16 leads IEC color coded for PageWriter TC70. Consisting of 4 addit Long Upgrade Kit 12-15/16 leads IEC color coded for PageWriter TC70. Consisting of 4 additional long lead assy (48" (1,22m)), 6 shorting plugs, 2 lead separators 3.4 DIA, 4 banana post adapters, 6 colored clips, 6 colored rings, 4 white base rings and instructions for use.The long additions lead sets come pre-assembled with the white base ring and the banana post adapters. 1 kit = 1 sales unit.
Catalog Number
989803151781
Brand Name
NOUN
Version/Model Number
TC ADDITIONAL LONG LEADS KIT: IEC
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"
Yes
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
-
Product Code
DSA
Product Code Name
CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)
Public Device Record Key
7ff82752-efc8-49dd-b7a9-7a8acb6a6464
Public Version Date
August 04, 2022
Public Version Number
8
DI Record Publish Date
April 28, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 323 |
| 3 | A medical device with high risk that requires premarket approval | 36 |
| U | Unclassified | 1 |