Duns Number:537208717
Device Description: The Riester camera system (RCS-100) is a portable and multifunctional electronic imaging d The Riester camera system (RCS-100) is a portable and multifunctional electronic imaging diagnostic system which consists of OT, DE, and GE three replaceable modules. This camera system is designed to be operated by anyone who is eighteen years and older or medical professionals to capture images and video in specified operating environment.
Catalog Number
1970-HDGO
Brand Name
RCS 100 Camera with dermatoscope, otoscope and
Version/Model Number
1970-HDGO
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"
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For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
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Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FTT
Product Code Name
Camera, Still, Surgical
Public Device Record Key
5dc05064-4871-4b05-a6de-4a552d94a406
Public Version Date
November 23, 2021
Public Version Number
2
DI Record Publish Date
July 19, 2021
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 | 282 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 332 |