Duns Number:958758146
Device Description: Standard Wipe Down Body Wedge Set (2 each - Short)
Catalog Number
BPW11
Brand Name
Wipe Down Body Wedge Set - Standard
Version/Model Number
BPW11
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 01, 2021
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
FMP
Product Code Name
Protector, Skin Pressure
Public Device Record Key
f692695c-ffd1-48ce-b3ed-cc0dd5549670
Public Version Date
July 27, 2021
Public Version Number
2
DI Record Publish Date
February 20, 2019
Package DI Number
10810006680062
Quantity per Package
11
Contains DI Package
00810006680065
Package Discontinue Date
July 01, 2021
Package Status
Not 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 | 208 |