Duns Number:073704413
Device Description: 30x20 EACHWHEELCHAIR CUSHION WITH COVER
Catalog Number
BPRT3020961
Brand Name
Span-America
Version/Model Number
Geo-Matt PRT
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
IMP
Product Code Name
Cushion, Wheelchair
Public Device Record Key
5e9340f0-2e40-4350-9244-d14fd148d7eb
Public Version Date
March 12, 2020
Public Version Number
1
DI Record Publish Date
March 04, 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 | 399 |
2 | A medical device with a moderate to high risk that requires special controls. | 711 |