Duns Number:663211978
Device Description: Model GB-3 Device emits heat from the heater and treats the afflicted part of the body, ha Model GB-3 Device emits heat from the heater and treats the afflicted part of the body, hands, legs, knee, shoulder etc. by placing it near the surface of the bare skin (at a distance directly over the skin surface).It is effective when deep heating of body tissue is desired.
Catalog Number
GD5208
Brand Name
GB-3
Version/Model Number
GD5208
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
6a46edf0-2559-4091-bf54-9e88d891f6b9
Public Version Date
April 07, 2021
Public Version Number
1
DI Record Publish Date
March 30, 2021
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. | 1 |
| U | Unclassified | 1 |