Duns Number:961027315
Device Description: STERILE ENT PACK
Catalog Number
SEN21ENPPA
Brand Name
CARDINAL HEALTH
Version/Model Number
SEN21ENPPA
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
OGR
Product Code Name
Ear, nose, and throat surgical tray (kit)
Public Device Record Key
c1b19767-56cb-4d16-b868-b10d58fb9536
Public Version Date
July 17, 2018
Public Version Number
3
DI Record Publish Date
July 14, 2016
Package DI Number
50887488376262
Quantity per Package
5
Contains DI Package
10887488376264
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 |