Duns Number:790605856
Device Description: Upgrade Kit 12-15/16 leads AAMI color coded for PageWriter TC 70. Consisting of 4 addition Upgrade Kit 12-15/16 leads AAMI color coded for PageWriter TC 70. Consisting of 4 additional lead assy (33" (0,84m)), 6 shorting plugs, 2 lead separators, 6 colored clips, 6 colored rings, 4 brown base rings and instructions for use. 1 kit = 1 sales unit.
Catalog Number
989803151751
Brand Name
NOUN
Version/Model Number
TC ADDITIONAL LEADS KIT: AAMI
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
f2621b17-af27-4f18-bfbc-779741eb5dc3
Public Version Date
August 04, 2022
Public Version Number
6
DI Record Publish Date
May 11, 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 |