Duns Number:962750381
Device Description: TearCare System Kit including the Controller, Charging Cradle, IFU, and Charger Adapter
Catalog Number
5-100
Brand Name
TearCare(TM) System Kit
Version/Model Number
FG 05509
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 30, 2019
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
IRT
Product Code Name
Pad, Heating, Powered
Public Device Record Key
8cb51158-64ea-46d8-963d-28f7473bac29
Public Version Date
October 27, 2020
Public Version Number
2
DI Record Publish Date
March 16, 2018
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. | 6 |