Duns Number:009452895
Device Description: mi-eye 2 probe 160mm length for use with Trice Tablet 2
Catalog Number
-
Brand Name
mi-eye 2 160mm
Version/Model Number
T200-160
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
K162475
Product Code
HRX
Product Code Name
Arthroscope
Public Device Record Key
79d3e934-d3a3-43f6-87ea-50a917a70b88
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 20, 2017
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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |