FDA UDI
Not 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
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Basic Information
- Brand Name
- Richmar
- Primary DI
- 00850030915214
- Version / Model
- RM-410-010
- Company Name
- South Dakota Partners Inc.
- Labeler DUNS
- 080639793
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-08-02
- Public Version
- 3
- Public Version Date
- 2025-04-04
- Public Version Status
- Update
- Public Device Record Key
- a18e9234-1a3d-428c-adb9-82ec35f1a919
- Distribution End Date
- 2024-08-19
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 (iontophoresis), 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 |