FDA UDI
In Commercial Distribution
🇺🇸 United States
Registration Marker Kit, Sterile, Single
DI: 00850044606016
·
Model: SPEC-0303
·
Mediview Xr, Inc.
Product Codes
1
GMDN Terms
2
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Registration Marker Kit, Sterile, Single
- Primary DI
- 00850044606016
- Version / Model
- SPEC-0303
- Company Name
- Mediview Xr, Inc.
- Labeler DUNS
- 117407269
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-10-23
- Public Version
- 2
- Public Version Date
- 2025-11-20
- Public Version Status
- Update
- Public Device Record Key
- 3d166d99-3d39-48ce-98bc-c40588c01369
Device Description
MediView single sterile Registration Marker kit for use with XR90.
Device Characteristics
- Single Use
- Yes
- 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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LLZ | System, Image Processing, Radiological | Radiology | 892.2050 | 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 |
| 58246 | Electromagnetic device tracking system spatial marker, non-powered | A non-powered, noninvasive device intended to provide a fixed reference point for the electromagnetic (EM) tracking of a patient and/or instruments during a surgically-invasive procedure, whereby tracking images are overlaid on pre-acquired and/or real-time images [e.g., computed tomography (CT), magnetic resonance imaging (MRI), ultrasound (US)]. Also referred to as a navigation fiducial marker or tracker, it typically consists of a radiopaque bracket-like device with an adhesive backing that is placed on the patient and allows the connection of an EM sensor for active registration. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10850044606013 | GS1 | 8 | In Commercial Distribution | ||
| Primary | 00850044606016 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K223125 | 000 |