FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 18033695727159
·
Model: F7255
·
FIAB SPA
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
Basic Information
- Brand Name
- NA
- Primary DI
- 18033695727159
- Version / Model
- F7255
- Catalog Number
- F7255
- Company Name
- FIAB SPA
- Labeler DUNS
- 439770017
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2020-05-14
- Public Version
- 1
- Public Version Date
- 2020-05-22
- Public Version Status
- New
- Public Device Record Key
- d651bf3a-4c84-4000-a8ac-5596dd663583
Device Description
LTC (low temperature cautery) F7255 model is a sterile bipolar battery operated disposable device used for the cauterization of tissues and capillary vessels. F7255 model is equipped with fine tip and reaches a maximum working temperature of 600°C (1100°F). It is mainly used for ophtalmology procedures, but is suitable to be used whenever a quick and precise cauterization is necessary, reducing possible damages to surroundings tissues.
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | 878.4400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35029 | Electrocautery system generator, battery-powered | A battery-powered device that produces and delivers a regulated electrical current used to heat the electrode tip or wire loop of a cutting instrument used during surgical intervention to burn or sear body tissue. It is used to stop bleeding (cauterization of blood vessels), to treat superficial skin lesions, e.g., the removal of warts, the removal of gastrointestinal polyps via an appropriate endoscope, or to occlude fallopian tubes during sterilization procedures. It will typically contain electronic circuits and have a built-in thermocoupler to help control the temperature at the electrode. This is not an electrosurgical diathermy system. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 08033695727152 | GS1 | ||||
| Primary | 18033695727159 | GS1 |
Customer Contacts
- Phone
- +390558497943
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K083428 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 40 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 25 – 95 Percent (%) Relative Humidity