FDA UDI
In Commercial Distribution
🇺🇸 United States
Richmar
DI: 00850030915214
·
Model: RM-410-010
·
South Dakota Partners Inc.
Product Codes
5
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Richmar
- Primary DI
- 00850030915214
- Version / Model
- RM-410-010
- Company Name
- South Dakota Partners Inc.
- Labeler DUNS
- 080639793
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-08-02
- Public Version
- 1
- Public Version Date
- 2023-08-10
- Public Version Status
- New
- Public Device Record Key
- a18e9234-1a3d-428c-adb9-82ec35f1a919
Device Description
Richmar CM2 RM-410-010
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
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | Neurology | 882.5890 | 2 |
| IPF | Stimulator, Muscle, Powered | Physical Medicine | 890.5850 | 2 |
| IMG | Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat | Physical Medicine | 890.5860 | 2 |
| IMI | Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat | Physical Medicine | 890.5300 | 2 |
| LIH | Interferential Current Therapy | Neurology | 882.5890 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66709 | Multi-modality electrotherapy system | An assembly of nonimplantable devices intended to apply multiple electrotherapy modalities (e.g., transcutaneous electrical nerve stimulation (TENS), galvanic stimulation, medicinal electrophoresis, interferential current) to various parts of the body for the treatment of multiple types of conditions (e.g., gynaecological, proctological, dermatological, neurological, dental and ENT). It consists of an electrically-powered control unit/generator and a handpiece with dedicated applicators/probes. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850030915214 | GS1 |