Duns Number:177667227
Device Description: Heating Pad
Catalog Number
-
Brand Name
Sunmark - McKesson
Version/Model Number
000731-501-000U
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
d99cb733-63ba-429b-a0bb-060d5b749ea0
Public Version Date
July 07, 2020
Public Version Number
4
DI Record Publish Date
December 15, 2016
Package DI Number
60038703920518
Quantity per Package
6
Contains DI Package
00038703920516
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 25 |