Duns Number:197386191
Catalog Number
-
Brand Name
DIY
Version/Model Number
DIYMITT
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
ILY
Product Code Name
Lamp, Infrared, Therapeutic Heating
Public Device Record Key
efc30c32-5cd3-45ca-a5bc-6355a326ad6a
Public Version Date
July 07, 2020
Public Version Number
3
DI Record Publish Date
October 03, 2016
Package DI Number
B347DIYMITT1
Quantity per Package
20
Contains DI Package
B347DIYMITT0
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. | 49 |