FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Localizer Headband
DI: EFIAE0122001
·
Model: 1
·
Fiagon GmbH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Localizer Headband
- Primary DI
- EFIAE0122001
- Version / Model
- 1
- Company Name
- Fiagon GmbH
- Labeler DUNS
- 312623008
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-05
- Public Version
- 7
- Public Version Date
- 2023-09-18
- Public Version Status
- Update
- Public Device Record Key
- eea92179-a8dc-4508-a51a-7337e8d5b3b6
- Distribution End Date
- 2023-07-18
Device Description
The product Localizer Headband is a product variant of a patient reference localisator. for image guided surgical procedures.The navigation system and its accessories are intended for use by healthcare professionals only. In addition, the users receive a training. The operator, i.e., the person or facility that is responsible for the use and service of the system, must ensure that all users of the system receive an adequate introduction into the system in accordance with valid laws and regulations. An operator is everyone who uses the system. The localizer as a part of the navigation system serves as a reference fixed to the patient. The instructions for use of the navigation system describe the proper use of the entire system in detail.
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
- MR Unsafe
- 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 |
|---|---|---|---|---|
| PGW | Ear, Nose, And Throat Stereotaxic Instrument | Neurology | 882.4560 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45199 | Multi-purpose stereotactic surgery system | An electrically-powered assembly of devices that typically consists of a rigid frame, positioning and alignment components, workstation, and a calibrated guide mechanism for precisely positioning probes, other instruments, or implantable devices during a surgical procedure of more than one discipline [e.g., orthopaedic and ear/nose/throat (ENT)]. The system may include computerized functions to store diagnostic images used for image-guided surgery. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | EFIAE0122001 | HIBCC | ||||
| Direct Marking | EFIAE0122000 | HIBCC |
Customer Contacts
- Phone
- +13364282241
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 0.035 | Kilogram | |
| Height | 15 | Millimeter | |
| Width | 30 | Millimeter | |
| Length | 45 | Millimeter |
Storage Conditions
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal
- Type
- Handling Environment Humidity
- Temperature Range
- 30 – 75 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 15 – 35 Degrees Celsius