Duns Number:041674552
Device Description: Underpad, 23" x 24"
Catalog Number
Not Applicable
Brand Name
MedSource Under pad
Version/Model Number
MS-U2324
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
Yes
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
NAB
Product Code Name
Gauze / Sponge,Nonresorbable For External Use
Public Device Record Key
0b7c22e6-7aee-4292-8e3f-112c691f2c18
Public Version Date
February 21, 2022
Public Version Number
2
DI Record Publish Date
August 23, 2021
Package DI Number
00840155411388
Quantity per Package
200
Contains DI Package
00816703027141
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 | 498 |
2 | A medical device with a moderate to high risk that requires special controls. | 90 |