Duns Number:896421240
Device Description: Hush™ Reusable Shielded Cable for EMG and IOM 2x0.7mm female touchproof, 2.0m (79"), 5-pin Hush™ Reusable Shielded Cable for EMG and IOM 2x0.7mm female touchproof, 2.0m (79"), 5-pin DIN, 1/pkg
Catalog Number
9013C0122
Brand Name
Keypoint
Version/Model Number
9013C0122
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)
Yes
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
daaa0bc5-4811-40e5-98df-ae4898eaf5b2
Public Version Date
October 26, 2020
Public Version Number
2
DI Record Publish Date
March 13, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 154 |