Duns Number:177939027
Device Description: AMC&E 5-lead DIN to Pinch Telemetry Leadset
Catalog Number
-
Brand Name
AMC&E
Version/Model Number
LW-309DS50/5AT
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 10, 2019
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
Yes
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
IKD
Product Code Name
Cable, Electrode
Public Device Record Key
a21c62bd-b1e5-4602-b766-bb55f271f16d
Public Version Date
March 19, 2021
Public Version Number
3
DI Record Publish Date
September 30, 2016
Package DI Number
30817357020831
Quantity per Package
25
Contains DI Package
10817357020837
Package Discontinue Date
March 19, 2021
Package Status
Not 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 | 49 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 178 |