Duns Number:790605856
Device Description: Long Upgrade Kit 12-15/16 leads AAMI color coded for PageWriter TC70. Consisting of 4 addi Long Upgrade Kit 12-15/16 leads AAMI color coded for PageWriter TC70. Consisting of 4 additional long lead assy (48", 1,22m)), 6 shorting plugs, lead separators, 6 colored clips, 6 colored rings, 4 brown base rings and instructions for use. The additional lead sets come pre-assembled with the brown base rings. 1 kit = 1 sales unit.
Catalog Number
989803151771
Brand Name
NOUN
Version/Model Number
TC ADDITIONAL LONG 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
28ade485-d39e-46a9-953a-ad66689a4e74
Public Version Date
August 04, 2022
Public Version Number
8
DI Record Publish Date
November 08, 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 |