Duns Number:047025993
Device Description: Sheepskin Wheelchair Grip Pads (White)
Catalog Number
-
Brand Name
Vive
Version/Model Number
CSH1041
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
December 30, 2022
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KNO
Product Code Name
Accessories, Wheelchair
Public Device Record Key
79078da2-16a5-48d8-86f6-0a7551b4e519
Public Version Date
August 15, 2022
Public Version Number
2
DI Record Publish Date
February 01, 2022
Package DI Number
10810041985337
Quantity per Package
20
Contains DI Package
00810041985330
Package Discontinue Date
December 30, 2022
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 | 480 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 87 |