Duns Number:867673159
Device Description: Walkers, All Types2-Button Alum Product Description: ENFERMERAS Deluxe Two Button Walker,4 Walkers, All Types2-Button Alum Product Description: ENFERMERAS Deluxe Two Button Walker,4/cs
Catalog Number
-
Brand Name
DRIVEMEDICAL
Version/Model Number
E-10200-4
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
23f6c5b7-58e3-42c0-a5b1-0761baeabd89
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
June 21, 2019
Package DI Number
00822383260181
Quantity per Package
4
Contains DI Package
50822383260186
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 |