Duns Number:801895244
Device Description: ColpoStar™ 1H Colposcope with Traditional Halogen Light
Catalog Number
-
Brand Name
ColpoStar™ 1H Colposcope
Version/Model Number
906135
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K871682
Product Code
HEX
Product Code Name
Colposcope (And Colpomicroscope)
Public Device Record Key
f67c8e32-c13d-4dec-85ee-684a1ebe398b
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
November 17, 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 |