FDA UDI
In Commercial Distribution
🇺🇸 United States
Medical Science Products
DI: 00864666000305
·
Model: 4040-SD
·
SAUVRE INTERNATIONAL, LTD.
Product Codes
1
GMDN Terms
1
Identifiers
5
Pkg Device Count
1
Basic Information
- Brand Name
- Medical Science Products
- Primary DI
- 00864666000305
- Version / Model
- 4040-SD
- Catalog Number
- 4040-SD
- Company Name
- SAUVRE INTERNATIONAL, LTD.
- Labeler DUNS
- 080557421
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-06-08
- Public Version
- 3
- Public Version Date
- 2021-02-19
- Public Version Status
- Update
- Public Device Record Key
- 797e0213-1102-48ba-b490-13f98ea1718b
Device Description
Transcutaneous electrical stimulation electrode, Square, 40x40mm
Device Characteristics
- Single Use
- No
- 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
- 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
- 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 |
|---|---|---|---|---|---|---|
| Package | 10864666000326 | GS1 | Box | 120 | In Commercial Distribution | |
| Package | 00864666000329 | GS1 | Bag | 24 | In Commercial Distribution | |
| Primary | 00864666000305 | GS1 | ||||
| Package | 10864666000319 | GS1 | Box | 400 | In Commercial Distribution | |
| Package | 00864666000312 | GS1 | Bag | 4 | In Commercial Distribution |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 40 | Millimeter | |
| Length | 40 | Millimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- – 45 Degrees Celsius