PowerMark

Primary DI
B971SL500
Brand
PowerMark
Company
Jessop Precision Products Inc.
Model
5.0mm lead ball on 15mm label
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
B971SL501PrimaryHIBCC0
B971SL500Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Skin marking stickerA hypoallergenic adhesive device (sticker) intended to be affixed to a patient’s skin (e.g., forehead) as a point of reference (marker), typically for use with external diagnostic imaging techniques. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
055127831
Device count
50
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
false
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

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
03613720287971UNiDâ„¢ 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