FDA.report

Stellar Medical

Primary DI
00853162006348
Brand
Stellar Medical
Company
STELLAR MEDICAL, LLC
Model
L0832SM
Device description
2, Loose 0.8 mm x 3 mm Gold Marker in Vial, 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

Related Records

Product Codes

CodeName
KXKSource, Brachytherapy, Radionuclide

Product Code Classifications

CodeDeviceSpecialtyClass
KXKSource, Brachytherapy, RadionuclideRadiology2

Premarket Submissions

SubmissionSupplement
K092041000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K092041000STELLAR FIDUCIAL MARKER, MODEL GFMIAStellar Medical, LLC2009-10-02IYE

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00853162006348PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00853162006348008531620063488531620063480853162006348

GMDN Terms

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
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 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

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20860000064549GammaTileGT MEDICAL TECHNOLOGIES, INC.KXK2024-04-29
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