Duns Number:867673159
Device Description: RollatorsAccessories Product Description: Nitro Slow Down Brake, 1PR
Catalog Number
-
Brand Name
DRIVEMEDICAL
Version/Model Number
10266-BRAKE
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
ITJ
Product Code Name
WALKER, MECHANICAL
Public Device Record Key
6bee8b98-5842-49d5-8af4-a457ce38189e
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
June 21, 2019
Package DI Number
50822383984303
Quantity per Package
25
Contains DI Package
00822383984308
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3783 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 832 |