Duns Number:016898496
Device Description: Balloon Bipolar Temporary Pacing Electrode Catheter, Stainless Steel Electrodes
Catalog Number
006172P
Brand Name
N/A
Version/Model Number
006172P
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)
Yes
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
-
Product Code
LDF
Product Code Name
ELECTRODE, PACEMAKER, TEMPORARY
Public Device Record Key
7e161946-4386-476d-a9e5-125ecf705133
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
June 29, 2015
Package DI Number
10801741011198
Quantity per Package
5
Contains DI Package
00801741011191
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CA
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 472 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1994 |
| U | Unclassified | 10 |