FDA UDI
In Commercial Distribution
🇺🇸 United States
ProStim Electrodes
DI: 00733657258356
·
Model: 31700
·
ALIMED, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- ProStim Electrodes
- Primary DI
- 00733657258356
- Version / Model
- 31700
- Catalog Number
- 31702
- Company Name
- ALIMED, INC.
- Labeler DUNS
- 056007248
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-01
- Public Version
- 4
- Public Version Date
- 2021-02-19
- Public Version Status
- Update
- Public Device Record Key
- 6d7bf290-5eb0-4b05-98cd-8a075e6e0512
Device Description
ProStim Electrodes, 2-3/4" Round
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| GXY | ELECTRODE, CUTANEOUS | Neurology | 882.1320 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35995 | Transcutaneous electrical stimulation electrode, single-use | An electrical conductor intended to be attached to a patient's skin (noninvasive) to provide therapeutic electrical stimuli through the body surface [e.g., transcutaneous electrical nerve stimulation (TENS), electrical muscle stimulation (EMS), cranial electrotherapy stimulation (CES)]. It is typically a flat, flexible, conductive pad with an adhesive (e.g., gel), or a preformed shape/mechanism designed for attachment to a particular body part (e.g., earclip), connected to a conductive wire. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00733657258356 | GS1 |
Customer Contacts
- Phone
- +1(781)329-2900 ext. 363
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K130987 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 2 | Inch | |
| Device Size Text, specify | Round |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Device kept at room temperature
- Type
- Storage Environment Temperature
- Temperature Range
- 59 – 86 Degrees Fahrenheit