Duns Number:023904428
Device Description: Therapy Putty x-firm resistance level 5 lb
Catalog Number
-
Brand Name
McKesson
Version/Model Number
169-10-1471
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
IOD
Product Code Name
Components, Exercise
Public Device Record Key
52035d5d-7e8d-4bd5-8d80-81592b3301aa
Public Version Date
April 08, 2022
Public Version Number
2
DI Record Publish Date
May 22, 2019
Package DI Number
00612479242180
Quantity per Package
4
Contains DI Package
00612479242173
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 | 870 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 422 |
| U | Unclassified | 44 |