Duns Number:063997360
Device Description: LDR Heating Pad Moist / Dry Electric 60-minute auto-off
Catalog Number
4125050
Brand Name
LEADER
Version/Model Number
4125050
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
IRT
Product Code Name
PAD, HEATING, POWERED
Public Device Record Key
6b4fdd1c-7cdd-4317-b6ce-8d635d44c196
Public Version Date
July 02, 2021
Public Version Number
4
DI Record Publish Date
December 27, 2017
Package DI Number
50096295116736
Quantity per Package
12
Contains DI Package
00096295116731
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 | 23 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 39 |