Duns Number:011920774
Device Description: Quality Choice 12" x 24" Deluxe Moist/Dry Heating Pad
Catalog Number
QC-99168
Brand Name
QUALITY CHOICE
Version/Model Number
89-510
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
IRT
Product Code Name
Pad, Heating, Powered
Public Device Record Key
285dc52c-0dfa-41ce-856b-d568d8ae5a3f
Public Version Date
July 07, 2020
Public Version Number
3
DI Record Publish Date
February 15, 2017
Package DI Number
30635515991683
Quantity per Package
3
Contains DI Package
00635515991682
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
INTERMEDIATE
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 10 |