Duns Number:006999858
Device Description: UNDERPAD QUILTED KAUM W/TUCK-INS 33X36 RM (98-7998) USE: 59750101
Catalog Number
597E0200
Brand Name
UNDERPAD QUILTED
Version/Model Number
597E0200
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FMW
Product Code Name
Cover, Mattress (Medical Purposes)
Public Device Record Key
a5bed606-c960-4152-ab99-b58d495e211e
Public Version Date
June 19, 2020
Public Version Number
3
DI Record Publish Date
January 29, 2018
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 | 26 |
2 | A medical device with a moderate to high risk that requires special controls. | 9 |