FDA UDI
In Commercial Distribution
🇺🇸 United States
Precision Pointer EM
DI: B057U1029010
·
Model: 1.0
·
Scopis GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Precision Pointer EM
- Primary DI
- B057U1029010
- Version / Model
- 1.0
- Catalog Number
- U1 029 01
- Company Name
- Scopis GmbH
- Labeler DUNS
- 341702266
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-01-04
- Public Version
- 3
- Public Version Date
- 2023-09-18
- Public Version Status
- Update
- Public Device Record Key
- 2d992b0e-be1d-4b42-9ee2-bbead0d616c6
Device Description
The Precision Pointer EM is an electromagnetically tracked instrument that is used to register the patient anatomy and to navigate within the anatomical space. The location of the instrument is referenced relative to a patient tracker that is attached to the patient. The pointer connects to the Hybrid Navigation Unit EM via an integrated cable. The Precision Pointer EM is provided non-sterile and is intended to be sterilized by the user. The Precision Pointer EM is reusable.
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
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| 58183 | Electromagnetic surgical navigation device tracking system | An assembly of devices intended to provide a physician with an electromagnetic (EM) tool for image registration and/or tracking of manual surgical instruments with respect to pre-acquired images (e.g., CT/MRI scan) or real-time data [e.g., ultrasound (US)] during surgery. It consists of a workstation with controls/display, a line-powered EM field generator, a tracking unit, instruments and trackers with sensors/spatial markers, and adhesive skin markers. It is used for multiple surgical procedures (e.g., ethmoidectomy, tumour resection, fibroid ablation, biopsy, drilling, vascular access) in various fields [e.g., ENT, craniomaxillofacial (CMF), laparoscopic, or orthopaedic surgery]. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B057U1029010 | HIBCC |