FDA.reportPublic FDA data

Theramark

Primary DI
B971TM251
Brand
Theramark
Company
Jessop Precision Products Inc.
Model
2.5mm Therapy Immobilization Mask Marker
Published
2021-10-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
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
B971TM251PrimaryHIBCC0
B971TM250Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Radiographic image marker, automaticA camera or image formatting unit that is a component of a diagnostic imaging system used to imprint identifying marks on: 1) photographic film or x-ray film (by exposure to visible light); or 2) digitally, on images created using various diagnostic imaging modalities [e.g., magnetic resonance imaging (MRI), x-ray or nuclear medicine]. Depending on the design of the marking system, it may be electronically or computer-controlled. Most frequently, it is used to imprint information on the images related to image acquisition parameters, patient identification, and to record anatomical information on individual images.

Contacts#

Phone, Email table
PhoneEmail
800-406-3399orders@suremark.com

Regulatory Flags#

DUNS number
055127831
Device count
110
Premarket exempt
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B971RTC120SuremarkRadTatRTC-122024-02-01
B971RTD12L0SuremarkRadTatRTD-12L2024-02-01
B971RTD12S0SuremarkRadTatRTD-12S2024-02-01
B971RTC121SuremarkRadTatRTC-122024-02-01
B971RTD12L1SuremarkRadTatRTD-12L2024-02-01
B971RTD12S1SuremarkRadTatRTD-12S2024-02-01
B971CF231DentalMark2.3mm CT ball on denture sized label2021-10-08
B971DM11ScaneezScaneez DentureMark Upper Central2021-10-08
B971DM21ScaneezScaneez DentureMark Upper Lateral2021-10-08
B971DM31ScaneezScaneez DentureMark Upper Cuspid2021-10-08
B971DM41ScaneezScaneez DentureMark Universal Bicuspid 2021-10-08
B971DM51ScaneezScaneez DentureMark Universal Molar2021-10-08
B971DM61ScaneezScaneez DentureMark Lower Cuspid2021-10-08
B971DM71ScaneezScaneez DentureMark Lower Incisor2021-10-08
B971DM81DentalMarkDentalMark 2.0mm flat fiducial markers2021-10-08
B971VF101DentalMarkDentalMark 1.0mm Visionline ball for Cone Beam CT2021-10-08
B971VF201DentalMarkDentalMark 2.0mm Visionline ball on denture sized 2021-10-08
B971RTC1000SuremarkRadTatRTC-1002023-01-16
B971RTL100SuremarkRadTatRTL-102023-01-16
B971BL151BeautyLine1.5mm lead ball on BeautyLine Butterfly label2021-10-08

Other Devices Sharing Product Codes#

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