Duns Number:690635461
Device Description: DS-10G is a digital hand-held camera used to record digital photographs and video of the h DS-10G is a digital hand-held camera used to record digital photographs and video of the human body.
Catalog Number
-
Brand Name
DIGITAL MEDICAL SCOPE
Version/Model Number
DS-10G
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
-
Product Code
FXF
Product Code Name
Speculum, Illuminated
Public Device Record Key
f77fc493-a19c-4002-9005-130ed1388427
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
January 31, 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 | 39 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 73 |
| 3 | A medical device with high risk that requires premarket approval | 5 |