FDA UDI In Commercial Distribution 🇺🇸 United States

RCS 100 Camera with dermatoscope, otoscope and

DI: 04045396211186 · Model: 1970-HDGO · Rudolf Riester GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
RCS 100 Camera with dermatoscope, otoscope and
Primary DI
04045396211186
Version / Model
1970-HDGO
Catalog Number
1970-HDGO
Company Name
Rudolf Riester GmbH
Labeler DUNS
537208717
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2021-07-19
Public Version
2
Public Version Date
2021-11-23
Public Version Status
Update
Public Device Record Key
5dc05064-4871-4b05-a6de-4a552d94a406

Device Description

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.

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
Yes
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
FTT Camera, Still, Surgical

GMDN Terms

Code Name
58857 Multi-purpose digital medical camera

Identifiers

Type ID
Primary 04045396211186