Duns Number:134139174
Device Description: FLEX-TIP TRANSLUMINAL A-PACING PROBE
Catalog Number
D98500
Brand Name
FLEX-TIP
Version/Model Number
D98500
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
K152633
Product Code
LDF
Product Code Name
ELECTRODE, PACEMAKER, TEMPORARY
Public Device Record Key
47b8824f-ed9a-4242-b855-f09845c80985
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 03, 2016
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 | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 643 |
| 3 | A medical device with high risk that requires premarket approval | 212 |