FDA UDI
In Commercial Distribution
🇺🇸 United States
LIBERTY
DI: H671PFS2000
·
Model: Stimulator
·
UTAH MEDICAL PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- LIBERTY
- Primary DI
- H671PFS2000
- Version / Model
- Stimulator
- Catalog Number
- PFS-200
- Company Name
- UTAH MEDICAL PRODUCTS, INC.
- Labeler DUNS
- 094651270
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 4
- Public Version Date
- 2024-08-27
- Public Version Status
- Update
- Public Device Record Key
- d303ed12-a9c1-47bf-ab50-21b5fdad8807
Device Description
Pelvic Floor Execiser System, Stimulator Unit, For use with Liberty execiser probes only, Includes Carrying Case, Batteries, and Instructional DVD
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
- 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 |
|---|---|---|---|---|
| KPI | Stimulator, Electrical, Non-Implantable, For Incontinence | Gastroenterology, Urology | 876.5320 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66773 | Perineal orifice incontinence-control electrical stimulation system generator | A noninvasive electrically-powered component of a perineal orifice incontinence-control electrical stimulation system designed to generate electrical signals (pulses) for treatment of urinary and/or faecal incontinence by a healthcare professional. It is designed to be connected to an intravaginal/intra-anal probe (not included) for delivery of the electrical stimuli which are intended to induce Kegel-like contractions in the muscles of the pelvic floor. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | H671PFS2000 | HIBCC |
Customer Contacts
- Phone
- 800-533-4984
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K960496 | 000 |
Storage Conditions
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 50 – 106 KiloPascal
- Type
- Handling Environment Humidity
- Temperature Range
- 10 – 100 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- -40 – 70 Degrees Celsius