Duns Number:010130626
Device Description: TS ACTIVATOR CLEAR, BOX OF 1, US
Catalog Number
0803-5001
Brand Name
TEARSCIENCE ACTIVATOR CLEAR
Version/Model Number
LFD-2100
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
Yes
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
ORZ
Product Code Name
Eyelid thermal pulsation system
Public Device Record Key
e83bb39e-8ee0-4a75-bab7-0091f5f33a40
Public Version Date
October 26, 2021
Public Version Number
1
DI Record Publish Date
October 18, 2021
Package DI Number
10810051250029
Quantity per Package
1
Contains DI Package
00810051250022
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 42 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 77 |
| 3 | A medical device with high risk that requires premarket approval | 3950 |