FDA UDI
In Commercial Distribution
🇺🇸 United States
PointerShell Universal
DI: 04260759930393
·
Model: E012904
·
Fiagon GmbH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- PointerShell Universal
- Primary DI
- 04260759930393
- Version / Model
- E012904
- Catalog Number
- E012904
- Company Name
- Fiagon GmbH
- Labeler DUNS
- 312623008
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-09-02
- Public Version
- 1
- Public Version Date
- 2024-09-10
- Public Version Status
- New
- Public Device Record Key
- aa73ffd5-55c7-4852-9457-10f0c2ee1da1
Device Description
The device PointerShell Universal is an instrument tracker adapter for image guided surgery for instruments shafts of 2.5mm to 5mm. The device is accessory to the Cube 4D Navigation system.
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 | 04260759930393 | GS1 | ||||
| Previous | EFIAE0129041 | HIBCC |
Customer Contacts
- Phone
- +13364282241
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K160479 | 000 |