Profile-ESP Radiographic marker

Primary DI
00868579000278
Brand
Profile-ESP Radiographic marker
Company
ORTHO KINEMATICS, INC.
Model
3.0
Device description
The Profile-ESP Radiographic Marker is an accessory for use within the Profile-ESP workflow of the VMA System. It can facilitate the conversion of measurement data by the Profile-ESP software to mm units, and facilitates stitching of spinal x-rays as part of the Image Processing service. The marker is placed around the neck of the patient by the medical imaging professional during x-ray imaging. It is shipped by Company personnel to the customer site and includes a user manual in the device package. No additional training or installation is required.Length – approximately 36” / Weight – approximately 5 oz.
Published
2019-02-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
JACSystem, X-Ray, Film Marking, Radiographic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JACSystem, X-Ray, Film Marking, RadiographicRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00868579000278PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00868579000278008685790002788685790002780868579000278

GMDN Terms#

Term, Definition table
TermDefinition
Radiographic image marker, manualAn object that is manually configured and physically placed within the field of view of a medical or dental diagnostic imaging system [e.g., x-ray, magnetic resonance imaging (MRI), or nuclear medicine] and leaves identifying marks on either films or digital images created using various diagnostic imaging modalities. It can be positioned either on a patient's body, or next to a patient, or be affixed to the film cassette or holder. It is made from materials compatible with the imaging system with which it is intended to be used. Typically used to imprint information on the images related to image acquisition parameters and/or patient identification, and to record anatomical information.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
932053221
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00868579000216VMA DataLink Software2.32016-09-22
00868579000223VMA DataLink Software32017-12-12
00868579000230VMA Image Acquisition Software32017-12-12
00868579000261Profile-ESP Bolster3.02019-02-14
00868579000209VMA22016-09-22
00868579000247VMA Motion Normalizer32018-01-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D800ZBAC6305RAY0Printer Resin X-Ray Temporary (500g)ZIRKONZAHN SRLJAC2026-05-20
30815112021505E-Z-MarkBracco Diagnostics Inc.JAC2026-01-09
00816589021219Fiducial Marker, SterileMONTERIS MEDICAL INCJAC2025-02-07
B201CGPAT0Clear Guide TP Access ToolCLEAR GUIDE MEDICAL, INC.JAC2025-01-10
B201CGTPF0Clear Guide TP Access FrameCLEAR GUIDE MEDICAL, INC.JAC2025-01-10
00815137022265RT-SPOTBeekley CorporationJAC2024-08-29
00815137022272RT-SPOTBeekley CorporationJAC2024-08-29
00815137022289RT-SPOTBeekley CorporationJAC2024-08-29
00815137022296RT-SPOTBeekley CorporationJAC2024-08-29
00815137022302RT-SPOTBeekley CorporationJAC2024-08-29
00815137022258RT-SPOTBeekley CorporationJAC2024-08-29
10815137022255RT-SPOTBeekley CorporationJAC2024-08-29
10815137022262RT-SPOTBeekley CorporationJAC2024-08-29
10815137022279RT-SPOTBeekley CorporationJAC2024-08-29
B971RTC120SuremarkJessop Precision Products Inc.JAC2024-02-01
B971RTD12L0SuremarkJessop Precision Products Inc.JAC2024-02-01
B971RTD12S0SuremarkJessop Precision Products Inc.JAC2024-02-01
B971RTC121SuremarkJessop Precision Products Inc.JAC2024-02-01
B971RTD12L1SuremarkJessop Precision Products Inc.JAC2024-02-01
B971RTD12S1SuremarkJessop Precision Products Inc.JAC2024-02-01
03701313007942K-BALLS.M.A.I.OJAC2023-12-22
03613720287971UNiD™ Calibration SphereMEDTRONIC SOFAMOR DANEK, INC.JAC2023-08-20
B971RTC1000SuremarkJessop Precision Products Inc.JAC2023-01-16
B971RTL100SuremarkJessop Precision Products Inc.JAC2023-01-16
00815137022166R-SPOTBeekley CorporationJAC2023-01-09
00815137022173L-SPOTBeekley CorporationJAC2023-01-09
10815137022163R-SPOTBeekley CorporationJAC2023-01-09
10815137022170L-SPOTBeekley CorporationJAC2023-01-09
B201CGVM20Clear Guide VisiMARKER IICLEAR GUIDE MEDICAL, INC.JAC2022-10-04
B201CGVM2NS0Clear Guide VisiMARKER II Non-SterileCLEAR GUIDE MEDICAL, INC.JAC2022-10-04