FDA UDI
Not in Commercial Distribution
🇺🇸 United States
PointerTube Sinus Frontalis
DI: EFIAE0121031
·
Model: 1
·
Fiagon GmbH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- PointerTube Sinus Frontalis
- Primary DI
- EFIAE0121031
- 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
- 2016-08-08
- Public Version
- 8
- Public Version Date
- 2023-09-18
- Public Version Status
- Update
- Public Device Record Key
- 965deaa9-fdce-407c-96ff-6ebcee19b05d
- Distribution End Date
- 2023-07-18
Device Description
The products are variants of a navigated suction instrument for image guided surgical procedures .The instruments are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. They are indicated for use with the Fiagon Navigation system using electromagnetic navigation. The instrument are indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure in the field of ENT surgery can be identified relative to a CT or MR based model of the anatomy.
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
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
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 | EFIAE0121031 | HIBCC | ||||
| Direct Marking | EFIAE0121030 | HIBCC |
Customer Contacts
- Phone
- +13364282241
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K141456 | 000 |
Storage Conditions
- Type
- Storage 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