FDA UDI
In Commercial Distribution
🇺🇸 United States
Richmar
DI: 00850030915313
·
Model: RM-201-4532
·
South Dakota Partners Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Richmar
- Primary DI
- 00850030915313
- Version / Model
- RM-201-4532
- 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
- 1ca820c2-e6fa-4319-b111-6d1ac1f44c3c
Device Description
Richmar Large Ionto4 Electrode, Bag of 12
Device Characteristics
- Single Use
- Yes
- 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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EGJ | Device, Iontophoresis, Other Uses | Physical Medicine | 890.5525 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46304 | Drug-delivery iontophoresis system electrode, active | A dedicated, active, electrical conductor that is a component of an iontophoresis system for transcutaneous drug delivery of a localized medication (e.g., corticosteroids or local anaesthetics). It is typically a layered pad that is attached to the skin surface of the patient at the target site, and connected to the current generator with a lead wire. An applied electric field causes the ionic-solution medication to transport from a reservoir within the pad for patient exposure. It comes in a variety of sizes. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10850030915310 | GS1 | Inner Pack | 2 | In Commercial Distribution | |
| Primary | 00850030915313 | GS1 | ||||
| Package | 20850030915317 | GS1 | Case | 12 | In Commercial Distribution |