Duns Number:070556204
Device Description: Curaplex 50mm X 48mm foam electrode, wet gel, 5 ea/strip, 2 strips/pouch
Catalog Number
2741-50486
Brand Name
Curaplex
Version/Model Number
2741-50486
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"
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
5c3b83ab-882a-477f-bf8c-f525468ccb9e
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 04, 2017
Package DI Number
00817617026558
Quantity per Package
10
Contains DI Package
00817617026596
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CS
| 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 |