FDA.reportPublic FDA data

Disposable Passive Sphere

Primary DI
04719878713207
Brand
Disposable Passive Sphere
Company
Taiwan Main Orthopaedic Biotechnology Co., Ltd.
Model
CDS-DPS-04
Published
2024-12-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
SBFOrthopedic Augmented Reality

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
SBFOrthopedic Augmented RealityNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719878713207PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719878713207047198787132074719878713207

GMDN Terms#

Term, Definition table
TermDefinition
Surgical planning/navigation-enhancement systemA mobile assembly of mains electricity (AC-powered) devices intended for both pre- and intraoperative applications to: 1) process medical imaging data to create a patient-specific, three-dimensional (3-D) model to enable a surgeon to plan/prepare for a surgical procedure; and 2) connect to a separate surgical navigation system to extract and display real-time surgical navigation information (e.g., navigation pointer) within the same 3-D model during surgery. It includes hardware [e.g., personal computer (PC), monitors, medical grade keyboard) and dedicated software. It is capable of collecting patient demographics, which may be anonymised.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
658875222
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
24719878713058Caduceus SCDS-022025-01-13
04719878713016Disposable Passive SphereCDS-DPS-002024-12-03
14719878713112Bone DrillMSI-PDL-012024-12-03
24719878713065Caduceus SCDS-022024-12-03
04719878713078HeadsetCDS-SSG-022024-12-02
04719878713085Connection SystemCDS-CNS-022024-12-02
04719878713337RouterCDS-RTR-022024-12-02
04719878713511Navigation CartCDS-NGC-032024-12-02
04719878713528Navi TrackerCDS-NTR-022024-12-02
04719878713542Navi TrackerCDS-NTR-042024-12-02
04719878713573Navi Tracker Mobile StanderCDS-NGC-042024-12-02
04719878713733Instrument HolderMSI-ITH-012024-12-02
04719878713801LaptopCDS-LTP-012024-12-02
14719878713099Minimally Invasive Spine Surgery InstrumentsMSI-022024-12-02
24719878713041Caduceus SCDS-022024-12-02

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