Duns Number:961027315
Device Description: Crutch Tips Replacement
Catalog Number
CACT20027R
Brand Name
CARDINAL HEALTH
Version/Model Number
CACT20027R
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
INP
Product Code Name
TIPS AND PADS, CANE, CRUTCH AND WALKER
Public Device Record Key
1bcebeab-9571-440f-a8b3-5159b1386440
Public Version Date
October 12, 2021
Public Version Number
1
DI Record Publish Date
October 04, 2021
Package DI Number
50885380187078
Quantity per Package
2
Contains DI Package
20885380187077
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 |