FDA UDI
In Commercial Distribution
🇺🇸 United States
Reusable Facial Patch
DI: 07290103421250
·
Model: PRP-40
·
NANOVIBRONIX INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Reusable Facial Patch
- Primary DI
- 07290103421250
- Version / Model
- PRP-40
- Company Name
- NANOVIBRONIX INC.
- Labeler DUNS
- 080326793
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-07-28
- Public Version
- 1
- Public Version Date
- 2019-08-05
- Public Version Status
- New
- Public Device Record Key
- b3a3c633-703f-4430-a4de-253a6d901bc2
Device Description
The Reusable Facial Patch is a small, lightweight treatment patch, which is attached to the user's skin at the location of the pain. The patch is energized with a signal from PainShield's driver and creates mechanical vibrations via the piezo-electric element. after the use patch should be covered with its original liner till next use.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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 |
|---|---|---|---|---|
| PFW | Stationary Ultrasonic Diathermy Device For Use In Applying Therapeutic Deep Heat | Physical Medicine | 890.5300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 11248 | Physical therapy ultrasound system | An assembly of devices designed to produce and deliver ultrasonic waves that penetrate tissues and produce both thermal and nonthermal (e.g., mechanical and cavitation) effects to treat pain (e.g., muscle, tendon, joint) and as an aid in the healing of soft-tissue injuries (e.g., ulcerations, bursitis). It typically consists of a radio-frequency (RF) generator (frequencies from one to three megahertz are typical), a cable that transmits the RF energy to the applicator, and an applicator including a piezoelectric transducer that applies the ultrasonic energy to the patient's tissues through the skin. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07290103421250 | GS1 |
Storage Conditions
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 40 – 60 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 27 Degrees Celsius