Duns Number:942011719
Device Description: Yang Guang TDP Lamp is one of the most reliable and durable far infrared mineral lamps in Yang Guang TDP Lamp is one of the most reliable and durable far infrared mineral lamps in the U.S.
Catalog Number
-
Brand Name
Yang Guang TDP Lamp
Version/Model Number
CQG-222AA/G-3
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
October 01, 2026
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
ILY
Product Code Name
Lamp, Infrared, Therapeutic Heating
Public Device Record Key
02a4581a-8bcb-4687-a9b1-048c81661013
Public Version Date
August 02, 2021
Public Version Number
5
DI Record Publish Date
September 23, 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. | 6 |
| U | Unclassified | 3 |