Duns Number:961027315
Device Description: ENDO BROW MRKR AND LBLS
Catalog Number
17I7817B
Brand Name
CARDINAL HEALTH
Version/Model Number
17I7817B
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"
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
FZZ
Product Code Name
MARKER, SKIN
Public Device Record Key
c1286c47-86f8-4440-8c90-c85c7e6ab05d
Public Version Date
September 10, 2019
Public Version Number
3
DI Record Publish Date
April 20, 2018
Package DI Number
50887488960287
Quantity per Package
50
Contains DI Package
10887488960289
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 |