Duns Number:062388929
Device Description: Disposable Underpads - 17" x 24", case of 300 ea
Catalog Number
8001
Brand Name
Strong Manufacturers
Version/Model Number
8001
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KME
Product Code Name
Bedding, Disposable, Medical
Public Device Record Key
93b802a2-08d0-475e-a93e-404936068ec6
Public Version Date
February 21, 2022
Public Version Number
2
DI Record Publish Date
November 12, 2021
Package DI Number
10850005354083
Quantity per Package
300
Contains DI Package
00850005354086
Package Discontinue Date
-
Package Status
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 | 79 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |