FDA.reportPublic FDA data

Kit, Aurora FG Mounting Brackets, LT

Primary DI
00850044606030
Brand
Kit, Aurora FG Mounting Brackets, LT
Company
Mediview Xr, Inc.
Model
XR90-BRK-FG-LT
Device description
The Field Generator Brackets are reusable devices that are used to attach and secure medical equipment, such as an electromagnetic field generator, to the underside of a compatible operating table for use during procedures performed with such equipment.
Published
2023-10-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
BWNTable And Attachments, Operating-Room
LLZSystem, Image Processing, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BWNTable And Attachments, Operating-RoomGeneral, Plastic Surgery1
LLZSystem, Image Processing, RadiologicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K223125000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223125000XR90 (XR90-SYS)Mediview Xr, Inc.2023-07-13LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850044606030PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850044606030008500446060308500446060300850044606030

GMDN Terms#

Term, Definition table
TermDefinition
Electromagnetic surgical navigation device tracking systemAn 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].

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
117407269
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850044606016Registration Marker Kit, Sterile, SingleSPEC-03032023-10-23
00850044606047Kit, Aurora FG Mounting Brackets, RTXR90-BRK-FG-RT2023-10-23
00860006066345EM Probe Bracket Kit, C1-6, SingleSPEC-0551XR90-PBRK-C16-012025-01-02
10860006066342EM Probe Bracket Kit, C1-6, SingleSPEC-0551XR90-PBRK-C16-012025-01-02
00860006066369XR90 System, LOGIQXR90-SYS-LOGIQ2025-01-02
00860006066376XR90 System, LOGIQ, Single HeadsetXR90-LQ-HMD012025-01-02
00860006066383XR90 System, LOGIQ, Upgrade KitXR90-LQ-UPGRADE2025-01-02
00850044606023EM Probe Bracket Kit, C1-5, SingleSPEC-0310XR90-PBRK-C15-012023-10-23
00850044606054XR90XR90-SYS2023-10-23
00850044606061OmnifyXROXR-SYS2023-11-01
00850044606009Triangle Template KitXR90-CT-KIT2023-10-24
10850044606013Registration Marker Kit, Sterile, SingleSPEC-03032023-10-23
00860006066307MediScout systemMS-100-10012021-04-20

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