Duns Number:007941230
Device Description: Wheelchair Replacement Calf Pad Fits All MediChoice Standard Heavy-Duty And Reclining Whee Wheelchair Replacement Calf Pad Fits All MediChoice Standard Heavy-Duty And Reclining Wheelchairs Not Nat Rubber Ltx Non Sterile Reusable MediChoice
Catalog Number
-
Brand Name
MediChoice
Version/Model Number
GEYCALFN
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
-
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
IMP
Product Code Name
CUSHION, WHEELCHAIR
Public Device Record Key
15a789b2-8ff8-4ea2-ae2c-833ee1c61206
Public Version Date
October 21, 2020
Public Version Number
1
DI Record Publish Date
October 13, 2020
Package DI Number
20885632063333
Quantity per Package
2
Contains DI Package
10885632063336
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 | 428 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8754 |
| U | Unclassified | 1 |