Theramark

Primary DI
B971TM250
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
Rx
false
OTC
false
Sterile
false
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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
055127831
Device count
110
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

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

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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
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10815137022170L-SPOTBeekley CorporationJAC2023-01-09
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