FDA UDI
In Commercial Distribution
🇺🇸 United States
Calibration body EM
DI: B057U1038020
·
Model: 1.0
·
Scopis GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Calibration body EM
- Primary DI
- B057U1038020
- Version / Model
- 1.0
- Catalog Number
- U1 038 02
- 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
- 6b17dc8b-6eda-46db-bb09-abca5f2607f7
Device Description
The Calibration body EM is used to calibrate a surgical endoscope which is tracked with Endoscope tracker EM. The location of the Calibration Body EM is referenced relative to the Endoscope tracker EM and allows Navigation Software NOVA AR to compute the optical parameters of the attached surgical endoscope. The Calibration body EM connects to the Hybrid Navigation Unit EM via an integrated cable. The Calibration body EM is provided non-sterile and is intended to be sterilized by the user. The Calibration body 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
- 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 |
|---|---|---|---|---|
| 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 | B057U1038020 | HIBCC |