Duns Number:058614483
Device Description: Multifilament Temporary Cardiac Pacing Lead
Catalog Number
-
Brand Name
Flexon
Version/Model Number
88862591-43
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 21, 2022
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
K955722,K955722
Product Code
LDF
Product Code Name
ELECTRODE, PACEMAKER, TEMPORARY
Public Device Record Key
0c5a8f5b-37fd-446a-bf4f-e4dfe6887bb4
Public Version Date
September 23, 2022
Public Version Number
8
DI Record Publish Date
August 31, 2015
Package DI Number
20884521103747
Quantity per Package
12
Contains DI Package
10884521103740
Package Discontinue Date
January 21, 2022
Package Status
Not in Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 132 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8540 |
| 3 | A medical device with high risk that requires premarket approval | 202 |
| U | Unclassified | 40 |