Duns Number:958758146
Device Description: Wipe Down Body Wedge Set, Rounded (1 each-BPW04R/ 1 each-BPW04LR) - 10/ST/CA
Catalog Number
BPW10R
Brand Name
Wipe Down Body Wedge Set, Rounded
Version/Model Number
BPW10R
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
FMP
Product Code Name
Protector, Skin Pressure
Public Device Record Key
71d5dde9-cb0f-4b03-a2f6-dbeca8dd237c
Public Version Date
August 03, 2021
Public Version Number
1
DI Record Publish Date
July 26, 2021
Package DI Number
10810006683841
Quantity per Package
10
Contains DI Package
00810006683844
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
SETS
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 208 |