FDA UDI
In Commercial Distribution
🇺🇸 United States
ST
DI: 07290016681277
·
Model: FS10011
·
FORMATK SYSTEMS LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ST
- Primary DI
- 07290016681277
- Version / Model
- FS10011
- Catalog Number
- FS10011
- Company Name
- FORMATK SYSTEMS LTD
- Labeler DUNS
- 532396673
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-08-18
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 0a7abea0-d7a5-473d-a9e6-f1f4266ddf9d
Device Description
Radiofrequency Applicator to be used with Formatk Systems Ltd supporting systems for minor muscle aches and pain treatments
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
- No
- 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 |
|---|---|---|---|---|
| PBX | Massager, Vacuum, Radio Frequency Induced Heat | General, Plastic Surgery | 878.4400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45213 | Radio-frequency skin contouring system applicator, bipolar | A bipolar handpiece that is part of a skin contouring system that uses radio-frequency (RF) energy to provide a capacitively coupled electrical connection for the transfer of radiated energy through a patient's skin in deep heat-mediated skin modification. The current passes between the two tips of this device during treatment, and not through the patient to a return electrode. This device is connected to a generator and is applied by the practitioner or staff directly to the area to be treated. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07290016681277 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K160195 | 000 |