Duns Number:867673159
Device Description: Raw MaterialsTurning Product Description: 7" Bed Wedge Cover, 1/ea
Catalog Number
-
Brand Name
DRIVEMEDICAL
Version/Model Number
2221038
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"
-
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
FMW
Product Code Name
COVER, MATTRESS (MEDICAL PURPOSES)
Public Device Record Key
166dfedb-1481-434e-b5ae-0a1e0ef8a69c
Public Version Date
July 15, 2019
Public Version Number
3
DI Record Publish Date
July 10, 2017
Package DI Number
50822383525810
Quantity per Package
100
Contains DI Package
00822383525815
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 | 3783 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 832 |