Duns Number:867673159
Device Description: Personal Care Aids to Daily Living Product Description 32" Foldable Reacher,1EA,6/CS
Catalog Number
-
Brand Name
DRIVE
Version/Model Number
RTL5021F
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 24, 2020
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
-
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
IKX
Product Code Name
AID, TRANSFER
Public Device Record Key
f88269e8-134d-4c30-ace0-3a142c71480b
Public Version Date
April 24, 2020
Public Version Number
2
DI Record Publish Date
February 08, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
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 |