FDA.reportPublic FDA data

Xact

Primary DI
00854623006044
Brand
Xact
Company
Solstice Corporation
Model
M10LT
Catalog number
M10LT
Device description
Tomo/3D imaging scar marker, 1cm perforations, 300 cm/box https://xactmarkers.com/product/tomography-scar-markers/
Published
2021-02-10
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
00854623006044PrimaryGS10
10854623006041Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854623006044008546230060448546230060440854623006044
1085462300604110854623006041

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-20 Degrees Celsius40 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
800-874-7922info@solsticecorp.com

Regulatory Flags#

DUNS number
609823877
Device count
300
Premarket exempt
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00854623006075Micro-TipA28PCA28PC2023-06-14
00854623006006XactM15SM15S2021-02-26
00854623006013XactM10TTM10TT2021-02-26
00854623006020XactM23SCM23SC2021-02-26
00854623006037XactM10LMM10LM2021-02-26
00854623006051XactM15RTM15RT2021-02-26
00854623006068XactM15RMM15RM2021-02-26
00854623006082XactM20SM20S2021-02-26
00854623006099XactM15SCM15SC2021-02-26
00854623006105XactM20SCM20SC2021-02-26
00854623006112XactM10TMM10TM2021-02-26
00854623006129XactM10RM10R2021-02-26
00854623006136XactM15RM15R2021-02-26
00854623006143XactM10ACM10AC2021-02-26
10854623006003XactM15SM15S2021-02-26
10854623006010XactM10TTM10TT2021-02-26
10854623006027XactM23SCM23SC2021-02-26
10854623006034XactM10LMM10LM2021-02-26
10854623006058XactM15RTM15RT2021-02-26
10854623006065XactM15RMM15RM2021-02-26

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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
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B971RTC1000SuremarkJessop Precision Products Inc.JAC2023-01-16
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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