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 | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FTT | Camera, Still, Surgical | General, Plastic Surgery | 878.4160 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58857 | Multi-purpose digital medical camera | An electrically-powered, hand-held digital electro-optical device designed to capture video or still image data for multiple medical applications (e.g., ophthalmoscopic, otoscopic, and dermatoscopic) using dedicated interchangeable lenses/attachments. It typically consists of a lightproof chamber with an aperture fitted with a lens and a shutter, through which the image of an object is projected onto a surface for recording. It may include a user display screen for visualization before image capture, and sometimes a docking cradle for battery recharging and connection to a personal computer. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04045396211186 | GS1 |