FDA.reportPublic FDA data

AOS Marker Seeds

Primary DI
00850645007007
Brand
AOS Marker Seeds
Company
ALPHA-OMEGA SERVICES, INC.
Model
SMG0242-025
Published
2024-07-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
JAQSystem, Applicator, Radionuclide, Remote-Controlled
KXKSource, Brachytherapy, Radionuclide

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JAQSystem, Applicator, Radionuclide, Remote-ControlledRadiology2
KXKSource, Brachytherapy, RadionuclideRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K233626000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233626000AOS Marker Seeds (SMG0242-025)Alpha-Omega Services, Inc.2024-07-02JAQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850645007007PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850645007007008506450070078506450070070850645007007

GMDN Terms#

Term, Definition table
TermDefinition
Radiological image marker, implantableA device intended to be implanted within the body, either temporarily or permanently, to create identifying marks that can be seen on radiological images. It is typically in the form of a wire, needle, bead, clip, stent-like tube, washer or fluid, 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. It is not an electromagnetic or optical spatial marker.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
060398989
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
false
Expiration date on label
false
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
00850645007601AOS Interstitial Templates, Needles, and AccesoriesNHD0001-0042024-07-18
00850645007618AOS Interstitial Templates, Needles, and AccesoriesNHD0001-0052024-07-18
00850645007625AOS Interstitial Templates, Needles, and AccesoriesTGD0003-0152024-07-18
00850645007632AOS Interstitial Templates, Needles, and AccesoriesTGD0003-0172024-07-18
00850645007649AOS Interstitial Templates, Needles, and AccesoriesTPD0001-0152024-07-18
00850645007656AOS Interstitial Templates, Needles, and AccesoriesTPD0001-0172024-07-18
00850645007076AOS Implant Needle, Series-17, 15 cm, 45°NID0001-0092016-10-05
00850645007083AOS implant Needle, Series-17, 20 cm, 14°NID0001-0102016-10-05
00850645007106AOS Implant Needle, Series-17, 20 cm, 45°NID0001-0122016-10-05
00850645007120AOS Implant Tube, Breast/Head/Neck, Puthawala/SyedTIB0001-0022016-10-05
00850645007137AOS Implant Tube, Breast/Head/Neck, Puthawala/SyedTIB0001-0032016-10-05
00850645007144AOS Implant Tube, IntralumenalTII0002-0012016-10-05
00850645007151AOS Implant Tube, IntralumenalTII0002-0022016-10-05
00850645007168AOS Implant Tube, IntralumenalTII0004-0012016-10-05
00850645007175AOS Implant Tube, IntralumenalTII0005-0012016-10-05
00850645007182AOS Implant Tube, IntralumenalTII0005-0062016-10-05
00850645007199AOS Implant Tube, IntralumenalTII0005-0112016-10-05
00850645007205AOS Implant TubeTIS0002-0022016-10-05
00850645007212AOS Implant Tube, Tongue/Soft Tissue, Puthawala/SyedTIT0001-0042016-10-05
00850645007229AOS Implant Tube, Tongue/Soft Tissue, Puthawala/SyedTIT0001-0052016-10-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
008152120213362PK 0.8X3.0MM GOLD FIDUCIAL LOOSEIzi Medical Products, LLCKXK2021-10-15
00813787021799TheragenicsTHERAGENICS CORPORATIONKXK2020-07-15
00813787021805TheragenicsTHERAGENICS CORPORATIONKXK2020-07-15
00813787021812TheragenicsTHERAGENICS CORPORATIONKXK2020-07-15
00813787021829TheragenicsTHERAGENICS CORPORATIONKXK2020-07-15
00813787021843TheragenicsTHERAGENICS CORPORATIONKXK2020-07-15
00813787021850TheragenicsTHERAGENICS CORPORATIONKXK2020-07-15
00813787021867TheragenicsTHERAGENICS CORPORATIONKXK2020-07-15
00813787021836TheragenicsTHERAGENICS CORPORATIONKXK2020-07-08
00853162006430Stellar MedicalSTELLAR MEDICAL, LLCKXK2020-05-28
00853162006447Stellar MedicalSTELLAR MEDICAL, LLCKXK2020-05-28
00853162006577Stellar MedicalSTELLAR MEDICAL, LLCKXK2020-05-28
00853162006607Stellar MedicalSTELLAR MEDICAL, LLCKXK2020-05-28
00853162006584Stellar MedicalSTELLAR MEDICAL, LLCKXK2019-05-29
00853162006454Stellar MedicalSTELLAR MEDICAL, LLCKXK2019-05-15
00853162006461Stellar MedicalSTELLAR MEDICAL, LLCKXK2019-05-15
00853162006478Stellar MedicalSTELLAR MEDICAL, LLCKXK2019-05-15
00853162006485Stellar MedicalSTELLAR MEDICAL, LLCKXK2019-05-15
00853162006492Stellar MedicalSTELLAR MEDICAL, LLCKXK2019-05-15
00853162006508Stellar MedicalSTELLAR MEDICAL, LLCKXK2019-05-15
00853162006515Stellar MedicalSTELLAR MEDICAL, LLCKXK2019-05-15
00853162006522Stellar MedicalSTELLAR MEDICAL, LLCKXK2019-05-15
00853162006539Stellar MedicalSTELLAR MEDICAL, LLCKXK2019-05-15
00853162006546Stellar MedicalSTELLAR MEDICAL, LLCKXK2019-05-15
00853162006553Stellar MedicalSTELLAR MEDICAL, LLCKXK2019-05-15
00853162006560Stellar MedicalSTELLAR MEDICAL, LLCKXK2019-05-15
00863593000235HDR MRI Lumen MarkerC4 IMAGING, LLCJAQ2018-06-11
00853162006423Stellar MedicalSTELLAR MEDICAL, LLCKXK2016-09-30
08717213043329X-ray CathetersNucletron B.V.JAQ2016-09-25
08717213043336X-ray CathetersNucletron B.V.JAQ2016-09-25