Duns Number:070556204
Device Description: Curaplex 50mm X 48mm foam electrode, wet gel, 5 ea/strip, 2 strip/pouch
Catalog Number
2741-50485
Brand Name
Curaplex
Version/Model Number
2741-50485
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"
Yes
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
DRX
Product Code Name
Electrode, electrocardiograph
Public Device Record Key
0158d07c-101c-4217-a251-04e4b8f9812c
Public Version Date
March 11, 2019
Public Version Number
1
DI Record Publish Date
February 10, 2019
Package DI Number
00812277034356
Quantity per Package
30
Contains DI Package
00812277034271
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 471 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 540 |
| 3 | A medical device with high risk that requires premarket approval | 3 |
| U | Unclassified | 1 |