Duns Number:023904428
Device Description: Premium Gel Cushion MOLDED GEL-INFUSED MEMORY FOAM GEL BLADDER MEDIAL AND LATERAL SIDE Premium Gel Cushion MOLDED GEL-INFUSED MEMORY FOAM GEL BLADDER MEDIAL AND LATERAL SIDE SUPPORTS TROCHANTER CUTOUTS 20 in x 18 in x 3 in
Catalog Number
-
Brand Name
McKesson
Version/Model Number
170-77009
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
d6928e41-e10e-42e4-8821-b02d06abe432
Public Version Date
May 10, 2021
Public Version Number
2
DI Record Publish Date
May 22, 2019
Package DI Number
00612479221307
Quantity per Package
4
Contains DI Package
00612479221291
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 |