FDA.reportPublic FDA data

Stellar Medical

Primary DI
00853162006300
Brand
Stellar Medical
Company
STELLAR MEDICAL, LLC
Model
1253SM
Device description
3, 17 ga x 20 cm needles, each containing 1, 1.2 x 5.0 mm gold marker, St
Published
2016-08-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KXKSource, Brachytherapy, Radionuclide

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KXKSource, Brachytherapy, RadionuclideRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K092041000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K092041000STELLAR FIDUCIAL MARKER, MODEL GFMIAStellar Medical, LLC2009-10-02IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00853162006300PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853162006300008531620063008531620063000853162006300

GMDN Terms#

Term, Definition table
TermDefinition
Imaging lesion localization marker, implantableA sterile device intended to be implanted within the body, either temporarily or permanently, to create identifying marks that can be seen on radiographic film or digital images. It is typically formed as a wire, needle, bead, stent-like tube or washer, and used to locate and delineate a tumour, lesion, or other site of interest. It is made from materials compatible with the imaging system with which it is intended to be used [e.g., magnetic resonance imaging (MRI), x-ray, or nuclear medicine]; it may be intended for use during radiotherapy procedures.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
015116092
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00853162006430Stellar Medical12102SM2020-05-28
00853162006447Stellar Medical1210230SM2020-05-28
00853162006577Stellar Medical083312SM2020-05-28
00853162006607Stellar MedicalL08320SM2020-05-28
00853162006584Stellar MedicalL1251SM2019-05-29
00853162006454Stellar MedicalL0454SM2019-05-15
00853162006461Stellar MedicalL1053SM2019-05-15
00853162006478Stellar Medical1210330SM2019-05-15
00853162006485Stellar Medical12103SM2019-05-15
00853162006492Stellar MedicalL08530SM2019-05-15
00853162006508Stellar MedicalL1055SM2019-05-15
00853162006515Stellar MedicalL1035SM2019-05-15
00853162006522Stellar Medical123430SM2019-05-15
00853162006539Stellar Medical12104SM2019-05-15
00853162006546Stellar Medical1210430SM2019-05-15
00853162006553Stellar Medical10104SM2019-05-15
00853162006560Stellar MedicalL08325SM2019-05-15
00853162006003Stellar Medical0451SM2016-08-17
00853162006010Stellar Medical08101SM2016-08-17
00853162006027Stellar Medical08103SM2016-08-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841365121425Best Medical InternationalBEST MEDICAL INTERNATIONAL, INC.KXK2025-12-16
M936IRLS15S9Advantage I-125ISOAID, L.L.C.KXK2025-03-04
M936IRLS15SS9Advantage I-125ISOAID, L.L.C.KXK2025-03-04
00850645007007AOS Marker SeedsALPHA-OMEGA SERVICES, INC.KXK2024-07-15
20860000064549GammaTileGT MEDICAL TECHNOLOGIES, INC.KXK2024-04-29
00860000064569CS-1GT MEDICAL TECHNOLOGIES, INC.KXK2024-04-29
00860000064576CS-1GT MEDICAL TECHNOLOGIES, INC.KXK2024-04-29
00860000064583PL-1GT MEDICAL TECHNOLOGIES, INC.KXK2024-04-29
00860000064590PL-5GT MEDICAL TECHNOLOGIES, INC.KXK2024-04-29
00860011485407PL-2GT MEDICAL TECHNOLOGIES, INC.KXK2024-04-29
00860011485414PL-3GT MEDICAL TECHNOLOGIES, INC.KXK2024-04-29
00860011485421PL-4GT MEDICAL TECHNOLOGIES, INC.KXK2024-04-29
00860011485438PL-4NSGT MEDICAL TECHNOLOGIES, INC.KXK2024-04-29
00860011485445PL-5MGT MEDICAL TECHNOLOGIES, INC.KXK2024-04-29
00860011485452PL-7GT MEDICAL TECHNOLOGIES, INC.KXK2024-04-29
00860011485469PL-8GT MEDICAL TECHNOLOGIES, INC.KXK2024-04-29
00841365120688Best Medical InternationalBEST MEDICAL INTERNATIONAL, INC.KXK2024-03-14
00841365120640Best Medical InternationalBEST MEDICAL INTERNATIONAL, INC.KXK2024-01-29
00841365120503Best Medical InternationalBEST MEDICAL INTERNATIONAL, INC.KXK2023-08-21
00841365120510Best Medical InternationalBEST MEDICAL INTERNATIONAL, INC.KXK2023-08-21
00841365120213Best Medical InternationalBEST MEDICAL INTERNATIONAL, INC.KXK2023-03-29
B887MRTLS050515200VISICOIL MR Twin LineRADIOMED CORPKXK2022-06-03
B887MRTLS075515180VISICOIL MR Twin LineRADIOMED CORPKXK2022-06-03
00813787022253TheraMark™THERAGENICS CORPORATIONKXK2022-05-25
00813787022260TheraMark™THERAGENICS CORPORATIONKXK2022-05-25
00813787022277TheraMark™THERAGENICS CORPORATIONKXK2022-05-25
00813787022284TheraMark™THERAGENICS CORPORATIONKXK2022-05-25
00813787022291TheraMark™THERAGENICS CORPORATIONKXK2022-05-25
00813787022307TheraMark™THERAGENICS CORPORATIONKXK2022-05-25
00813787022314TheraMark™THERAGENICS CORPORATIONKXK2022-05-25