FDA.reportPublic FDA data

IOPS®

Primary DI
10843152102058
Brand
IOPS®
Company
CENTERLINE BIOMEDICAL, INC.
Model
H01035
Catalog number
H01035
Device description
Guidewire Handle
Published
2024-11-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K242133000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242133000Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative Positioning System (IOPS®) (Guidewire Handle)Centerline Biomedical, Inc.2024-10-11DQK

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].

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080088507
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
00843152102051IOPS®H01035H010352024-11-11
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
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
05415067055811EnSite™ST. JUDE MEDICAL, INC.DQK2026-06-01
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
00199874185187Vektor Medical vMap SoftwareVektor Medical, Inc.DQK2026-05-08
00195278620873MACGe Medical Systems Information Technologies, Inc.DQK2026-03-31
00195278507037Mac-LabGe Medical Systems Information Technologies, Inc.DQK2026-03-26
00198953107263MACGe Medical Systems Information Technologies, Inc.DQK2026-01-27
00191506052454MDU5 Plus™BOSTON SCIENTIFIC CORPORATIONDQK2025-12-09
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
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
00191506033002AVVIGO™+BOSTON SCIENTIFIC CORPORATIONDQK2023-10-10
00191506033125AVVIGO™+BOSTON SCIENTIFIC CORPORATIONDQK2023-10-10
00191506033194AVVIGO™+BOSTON SCIENTIFIC CORPORATIONDQK2023-10-10
00191506033200AVVIGO™+BOSTON SCIENTIFIC CORPORATIONDQK2023-10-10
17540262170016Change Healthcare Cardiology HemodynamicsChange Healthcare Canada CompanyDQK2023-09-19
00195278522313CARESCAPE Canvas Smart DisplayGE Healthcare Finland OyDQK2023-04-19
00195278522320CARESCAPE Canvas 1000GE Healthcare Finland OyDQK2023-04-19
00195278523365CARESCAPE Canvas D19GE Healthcare Finland OyDQK2023-04-19