FDA UDI
In Commercial Distribution
🇺🇸 United States
UltraStick - HJ & Associates PL
DI: 00092237900925
·
Model: 203-818
·
COMPASS HEALTH BRANDS CORP.
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
Basic Information
- Brand Name
- UltraStick - HJ & Associates PL
- Primary DI
- 00092237900925
- Version / Model
- 203-818
- Company Name
- COMPASS HEALTH BRANDS CORP.
- Labeler DUNS
- 827221698
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-01-18
- Public Version
- 3
- Public Version Date
- 2023-08-08
- Public Version Status
- Update
- Public Device Record Key
- e96f2d27-6506-4278-b568-eebb634f8f2b
Device Description
2"x 3.5" Foam
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- 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 | 80092237900921 | GS1 | Master carton | 40 | In Commercial Distribution | |
| Package | 30092237900926 | GS1 | Inner Carton | 10 | In Commercial Distribution | |
| Primary | 00092237900925 | GS1 | ||||
| Unit of Use | 01092237900924 | GS1 |
Customer Contacts
- Phone
- 800-376-7263
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K050469 | 000 |