Duns Number:055363428
Device Description: PRO-PADZ LIQUID GEL RADIOLUCENT MFE, 1 SET
Catalog Number
-
Brand Name
PRO PADZ
Version/Model Number
8900-2106-01
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
DTE
Product Code Name
PULSE-GENERATOR, PACEMAKER, EXTERNAL
Public Device Record Key
68f67448-6b2b-40be-b4b9-327741508a97
Public Version Date
February 08, 2022
Public Version Number
3
DI Record Publish Date
September 24, 2014
Package DI Number
10847946016408
Quantity per Package
12
Contains DI Package
00847946016401
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 |