Duns Number:061228290
Device Description: Model 70036 XINFENG TDP Lamp is made from a famous tdp lamp manufacturer in China. Floor T Model 70036 XINFENG TDP Lamp is made from a famous tdp lamp manufacturer in China. Floor Type Style Lamp is contents 2 replaceable large (6.75") heads with 2 individual manual controllers. it's a durable and safety lamp with 5 metal legs base with 1 lockable wheel. This lamp is certificated FDA, CE, ISO and UL. Included 2 fuse and instruction menu. Sold by Each.
Catalog Number
70036
Brand Name
XinFeng TDP Heat Lamp
Version/Model Number
70036
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
ILY
Product Code Name
Lamp, Infrared, Therapeutic Heating
Public Device Record Key
1c729864-d2e6-494b-b9a0-0651206a62b4
Public Version Date
May 08, 2018
Public Version Number
3
DI Record Publish Date
November 05, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 51 |