Duns Number:961027315
Device Description: KNEE ARTHROSCOPY PACK
Catalog Number
SOP54KAWMF
Brand Name
CARDINAL HEALTH
Version/Model Number
SOP54KAWMF
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
OJH
Product Code Name
Orthopedic tray
Public Device Record Key
f96a4282-9207-4d7e-8216-6d977d40fe24
Public Version Date
July 23, 2018
Public Version Number
2
DI Record Publish Date
May 29, 2018
Package DI Number
50887488998464
Quantity per Package
1
Contains DI Package
10887488998466
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 |