FDA.reportPublic FDA data

Disposable Passive Sphere

Primary DI
04719878713016
Brand
Disposable Passive Sphere
Company
Taiwan Main Orthopaedic Biotechnology Co., Ltd.
Model
CDS-DPS-00
Published
2024-12-03
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
OLOOrthopedic Stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLOOrthopedic Stereotaxic InstrumentNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719878713016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719878713016047198787130164719878713016

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
14719878713112Bone DrillMSI-PDL-012024-12-03
24719878713065Caduceus SCDS-022024-12-03
04719878713078HeadsetCDS-SSG-022024-12-02
04719878713085Connection SystemCDS-CNS-022024-12-02
04719878713207Disposable Passive SphereCDS-DPS-042024-12-02
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00852776006713CORUS Navigation Access System-G2LXProvidence Medical Technology, Inc.OLO2026-10-26
00887868573040Sesamoid® SystemOrthosoft IncOLO2026-10-26
00887868573057Sesamoid® SystemOrthosoft IncOLO2026-10-26
00887868579608ROSA® RoboticsOrthosoft IncOLO2026-10-26
00887868579615ROSA® RoboticsOrthosoft IncOLO2026-10-26
00887868579622ROSA® RoboticsOrthosoft IncOLO2026-10-26
00887868579639ROSA® RoboticsOrthosoft IncOLO2026-10-26
00887868579646ROSA® RoboticsOrthosoft IncOLO2026-10-26
00889024705999NavitrackerOrthosoft IncOLO2026-10-26
00763000777500MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OLO2026-10-25
00763000777623MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OLO2026-10-25
00763000786434MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OLO2026-10-25
00763000777616CD HORIZON® Fenestrated Screw Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OLO2026-10-23
04056481146207Spine PlanningBrainlab SEOLO2026-10-23
00840466901011PrimusSPINAL ELEMENTS, INC.OLO2026-10-22
00840606184656OverwatchSPINAL ELEMENTS, INC.OLO2026-10-22
00840606187503OverwatchSPINAL ELEMENTS, INC.OLO2026-10-22
00840606187527OverwatchSPINAL ELEMENTS, INC.OLO2026-10-22
00840606187541OverwatchSPINAL ELEMENTS, INC.OLO2026-10-22
04056481147112RT ElementsBrainlab SEOLO2026-10-22
00190376632919InvictusALPHATEC SPINE, INC.OLO2026-10-20
00889024699762ROSA® ShoulderOrthosoft IncOLO2026-06-26
00889024699779ROSA® ShoulderOrthosoft IncOLO2026-06-26
00889024699786ROSA® ShoulderOrthosoft IncOLO2026-06-26
00889024699793ROSA® ShoulderOrthosoft IncOLO2026-06-26
00889024699809ROSA® ShoulderOrthosoft IncOLO2026-06-26
00889024699816ROSA® ShoulderOrthosoft IncOLO2026-06-26
00889024699823ROSA® ShoulderOrthosoft IncOLO2026-06-26
00887868581083ROSA® RoboticsOrthosoft IncOLO2026-02-20
00889024703186ROSA® ShoulderOrthosoft IncOLO2026-01-27