Duns Number:084527241
Device Description: This pad is designed for use with various Mizuho OSI leg supports.Dimensions: 17x12x1 inch This pad is designed for use with various Mizuho OSI leg supports.Dimensions: 17x12x1 inches.Made with Tempur-Pedic® Medical materials
Catalog Number
5840-7030
Brand Name
PAD, SUPPORT, 1"
Version/Model Number
5840-7030
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"
Yes
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
7bd046e5-40c7-4b7f-9c3d-944ec83a5090
Public Version Date
November 19, 2020
Public Version Number
3
DI Record Publish Date
June 30, 2017
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 | 1076 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 44 |