Duns Number:004249462
Device Description: MICRO-TEMP® LT Model 749 Localized Heat Therapy System.
Catalog Number
88116
Brand Name
Micro-Temp LT
Version/Model Number
749
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
ILO
Product Code Name
Pack, Hot Or Cold, Water Circulating
Public Device Record Key
ba5759c2-2057-4d24-bca7-4093c5fe6a87
Public Version Date
September 23, 2021
Public Version Number
3
DI Record Publish Date
May 18, 2016
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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 26 |