Duns Number:796269165
Device Description: CS-205T-LED Colposcope Center Post, Trinocular Zoom Head, Five Legged Base. LED Illuminati CS-205T-LED Colposcope Center Post, Trinocular Zoom Head, Five Legged Base. LED Illumination.
Catalog Number
CS-205T-LED
Brand Name
UNICO ColpoMaster II
Version/Model Number
CS-205T-LED
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K073053
Product Code
HEX
Product Code Name
Colposcope (And Colpomicroscope)
Public Device Record Key
5da4cebe-bfe7-488a-b6b8-485ae4ff25c0
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 23, 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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 10 |