Duns Number:801895244
Device Description: OPTIK Model 2 Colposcope; 3 MAG 1.0" Photo B-O-M Scope with Canon dSLR Kit
Catalog Number
-
Brand Name
LEISEGANG
Version/Model Number
OPTIK2-05-002
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K940094
Product Code
HEX
Product Code Name
Colposcope (And Colpomicroscope)
Public Device Record Key
ee873f77-1221-4777-ac90-2667199a0908
Public Version Date
October 12, 2018
Public Version Number
4
DI Record Publish Date
July 29, 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 | 29 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1471 |
| 3 | A medical device with high risk that requires premarket approval | 2 |