Duns Number:961027315
Device Description: Rigid Light Handle Cover
Catalog Number
ECH-01
Brand Name
CARDINAL HEALTH
Version/Model Number
ECH-01
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
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
FTA
Product Code Name
Light, surgical, accessories
Public Device Record Key
cd9e6cf2-6a81-45cf-af36-1c85bbb6bf14
Public Version Date
October 23, 2020
Public Version Number
5
DI Record Publish Date
September 01, 2016
Package DI Number
50885380000681
Quantity per Package
24
Contains DI Package
10885380000683
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 101686 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 139430 |
| 3 | A medical device with high risk that requires premarket approval | 8 |
| U | Unclassified | 40 |