FDA.reportPublic FDA data

IOPS®

Primary DI
00843152102051
Brand
IOPS®
Company
Centerline Biomedical, Inc.
Model
H01035
Catalog number
H01035
Device description
Guidewire Handle
Published
2024-11-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DQKComputer, Diagnostic, Programmable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQKComputer, Diagnostic, ProgrammableCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10843152102058PackageGS15In Commercial Distribution
00843152102051PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084315210205810843152102058
00843152102051008431521020518431521020510843152102051

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].

Regulatory Flags#

DUNS number
080088507
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
00843152100002IOPS Mobile CartMC-1MC-12020-09-18
00843152101078IOPS ViewpointC01251C012512024-10-01
00843152101108IOPS ViewpointC00752C007522024-10-01
00843152101115IOPS ViewpointC01252C012522024-10-01
00843152102037IOPS™ATW-2ATW-22020-09-18
00843152101061IOPS ViewpointC00751C007512024-10-01
00843152100057IOPS Visionary SystemMC-32026-02-24
00843152101023IOPS™SCC-1SCC-12020-09-18
00843152101030IOPS™RCC-1RCC-12020-09-18
00843152102013IOPS™SSH-1SSH-12020-10-21
00843152103003IOPS™TP-1TP-12020-09-18
00843152103027IOPS®T02111T021112025-03-18
00843152104000IOPS™ Software ApplicationSW-1SW-12020-09-18
10843152102034IOPS™ATW-2ATW-22020-09-18
10843152103024IOPS®T02111T021112025-03-18
10843152102058IOPS®H01035H010352024-11-11
10843152101075IOPS ViewpointC01251C012512024-10-01
10843152101105IOPS ViewpointC00752C007522024-10-01
10843152101112IOPS ViewpointC01252C012522024-10-01
10843152103000IOPS™TP-1TP-12020-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884838118898IECGPhilips Medizin Systeme Böblingen GmbHDQK2026-06-23
05415067055811EnSite™ST. JUDE MEDICAL, INC.DQK2026-06-01
00854277008197NorthStar Mapping SystemImricor Medical Systems, Inc.DQK2026-05-21
08719689142124QMAPP Fysicon B.V.DQK2026-05-19
08719689142131QMAPP Fysicon B.V.DQK2026-05-19
08719689142162QMAPP Fysicon B.V.DQK2026-05-19
08719689142179QMAPP Fysicon B.V.DQK2026-05-19
17540279200027CardioSTATIcentia Inc.DQK2025-12-08
08800069700109AT-ReportATsens Co., Ltd.DQK2025-11-05
08800069700246ATACC-C130AATsens Co., Ltd.DQK2025-11-05
08800069700260AT-PatchATsens Co., Ltd.DQK2025-11-05
08800069700277AT-PatchATsens Co., Ltd.DQK2025-11-05
B353UA2251DA1UbiqVueLifesignals, Inc.DQK2025-04-22
B353UA2251SA1UbiqVueLifesignals, Inc.DQK2025-04-22
27540279250029CardioSTATIcentia Inc.DQK2024-12-18
27540279250074CardioSTATIcentia Inc.DQK2024-12-18
27540279250142CardioSTATIcentia Inc.DQK2024-12-18
G637CEA0Cardiologs PlatformPHILIPS FRANCEDQK2024-09-23
17540279105018EARTIcentia Inc.DQK2024-03-26
17540279200072CardioSTATIcentia Inc.DQK2024-03-26
17540279200140CardioSTATIcentia Inc.DQK2024-03-26
17540262170016Change Healthcare Cardiology HemodynamicsChange Healthcare Canada CompanyDQK2023-09-19
08800069700178AT-PatchATsens Co., Ltd.DQK2022-12-23
B273CEA0Cardiologs PlatformCARDIOLOGS TECHNOLOGIESDQK2021-12-08
08714729982845MDU5 PLUSBOSTON SCIENTIFIC CORPORATIONDQK2021-11-29
08714729982852MDU5 PLUSBOSTON SCIENTIFIC CORPORATIONDQK2021-11-29
08714729982876MDU5 PLUSBOSTON SCIENTIFIC CORPORATIONDQK2021-11-29
00191506015084AVVIGO™ Guidance System IIBOSTON SCIENTIFIC CORPORATIONDQK2021-11-17
00191506015169AVVIGO™ Guidance System IIBOSTON SCIENTIFIC CORPORATIONDQK2021-11-17
00191506015176AVVIGO™ Guidance System IIBOSTON SCIENTIFIC CORPORATIONDQK2021-11-17