Duns Number:101835833
Device Description: Reusable Extension Cable
Catalog Number
ATAR-MDTR
Brand Name
ATAR MDTR
Version/Model Number
ATAR-MDTR
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 09, 2018
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
K070926
Product Code
IKD
Product Code Name
CABLE, ELECTRODE
Public Device Record Key
b82c48cc-4184-487d-a01a-98067cc56f34
Public Version Date
February 05, 2021
Public Version Number
5
DI Record Publish Date
October 03, 2017
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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 592 |
3 | A medical device with high risk that requires premarket approval | 16 |