FDA.reportPublic FDA data

CT-Markers

Primary DI
08717213051072
Brand
CT-Markers
Company
Nucletron B.V.
Model
110614P01
Device description
CT Marker 100mm, Green
Published
2016-10-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
08717213038752Direct MarkingGS10
08717213039049PackageGS11In Commercial Distribution
08717213051072PrimaryGS10
88717213038758Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08717213038752087172130387528717213038752
08717213039049087172130390498717213039049
08717213051072087172130510728717213051072
8871721303875888717213038758

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose brachytherapy system applicator, remote-afterloadingA general-purpose remote-afterloading brachytherapy applicator intended to be used to facilitate the delivery of radiation therapy treatments in a range of anatomical regions (e.g., liver, kidneys, lungs, gastrointestinal tract). It is designed for temporary introduction into the body and functions as a guide for computer-controlled placement and removal of single or multiple radioactive sources in a treatment area. This device includes a variety of applicators (e.g., hollow needle, tube, catheter), and their associated components [e.g., introducer sheath, guidewire].

Contacts#

Phone, Email table
PhoneEmail
+1(770)300-9725info.america@elekta.com

Regulatory Flags#

DUNS number
415269930
Device count
3
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08717213041288X-ray Catheters101066P01-012016-09-10
08717213041295X-ray Catheters101067P01-012016-09-10
08717213041301X-ray Catheters101068P01-012016-09-10
08717213041318X-ray Catheters101069P01-012016-09-10
08717213041721NA089401P01-012016-09-10
08717213042513X-ray Catheters084881P01-002016-09-10
08717213042520X-ray Catheters084882P01-002016-09-10
08717213042537X-ray Catheters085076P01-002016-09-10
08717213042544X-ray Catheters085077P01-002016-09-10
08717213042551X-ray Catheters085078P01-002016-09-10
08717213042568X-ray Catheters085079P01-002016-09-10
08717213042605X-ray Catheters089423P01-002016-09-10
08717213042612X-ray Catheters089424P01-002016-09-10
08717213042629X-ray Catheters089425P01-002016-09-10
08717213042636X-ray Catheters089426P01-002016-09-10
08717213042643X-ray Catheters089427P01-002016-09-10
08717213042650X-ray Catheters089428P01-002016-09-10
08717213042667X-ray Catheters089429P01-002016-09-10
08717213042674X-ray Catheters089430P01-002016-09-10
08717213042681X-ray Catheters089431P01-002016-09-10

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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