Duns Number:055363428
Device Description: PEDI*PADZ PEDIATRIC MULTI-FUNCTION ELECTRODES - 1 PAIR
Catalog Number
-
Brand Name
PEDI-PADZ
Version/Model Number
8900-2061
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"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DRF
Product Code Name
CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
Public Device Record Key
6cdcc851-2e8f-41c0-a615-5610d952231b
Public Version Date
February 08, 2022
Public Version Number
3
DI Record Publish Date
September 24, 2014
Package DI Number
10847946001466
Quantity per Package
6
Contains DI Package
00847946001469
Package Discontinue Date
-
Package Status
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 | 10 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1473 |
| 3 | A medical device with high risk that requires premarket approval | 1032 |