FDA.reportPublic FDA data

PL-8

Primary DI
00860011485469
Brand
PL-8
Company
GT MEDICAL TECHNOLOGIES, INC.
Model
PL-8
Device description
Cesium-131 Implant Devices combined with MRI Markers will be used to facilitate the anatomical location of seeds after they have been implanted in the prostate of a patient with confirmed prostatic malignancy. The PL-8 device is preloaded strands with Markers in 18G needles.
Published
2024-04-29
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Conditional
Rx
true
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
K202267000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202267000Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge NeedlesIsoray Medical, Inc.2020-12-31KXK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M748PL80PreviousHIBCC0
00860011485469PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860011485469008600114854698600114854690860011485469

GMDN Terms#

Term, Definition table
TermDefinition
Prostate brachytherapy system applicator, manualA manual brachytherapy applicator specifically designed to be used in radiation therapy treatments of the prostate. It is an individual or modular device designed to facilitate manual placement, e.g., puncture, endoscopically guided or diagnostic imaging system guided placement, and/or removal of single or multiple radioactive sources at a treatment site within the prostate. The device may be a fixed design or designed to accommodate individual patient source placement configurations and includes prostate applicators such as hollow needles, tubes or catheters, used in manual brachytherapy applications.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
081299204
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860011485452PL-7PL-72024-04-29
00860000064545GammaTileGT-0012024-04-29
20860000064549GammaTileGT-0012024-04-29
00860000064569CS-1CS-12024-04-29
00860000064576CS-1CS-1NS2024-04-29
00860000064583PL-1PL-12024-04-29
00860000064590PL-5PL-52024-04-29
00860011485407PL-2PL-22024-04-29
00860011485414PL-3PL-32024-04-29
00860011485421PL-4PL-42024-04-29
00860011485438PL-4NSPL-4NS2024-04-29
00860011485445PL-5MPL-5M2024-04-29
00860000064514GammaTile Radiation Shielding TrayGT-0022022-09-13
00860000064507GammaTile™GT-0012018-09-01
60860000064509GammaTile™GT-0012018-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M936IIS4721IsoSphereISOAID, L.L.C.KXK2026-05-12
M936IRLS15SSS9Advantage I-125ISOAID, L.L.C.KXK2025-03-04
00850645007007AOS Marker SeedsALPHA-OMEGA SERVICES, INC.KXK2024-07-15
B887MRTLS050515200VISICOIL MR Twin LineIzi Medical Products, LLCKXK2022-06-03
B887MRTLS075515180VISICOIL MR Twin LineIzi Medical Products, LLCKXK2022-06-03
M936IRLS20S9Advantage I-125®ISOAID, L.L.C.KXK2022-02-07
M936IRLS20SS9Advantage I-125®ISOAID, L.L.C.KXK2022-02-07
008152120213362PK 0.8X3.0MM GOLD FIDUCIAL LOOSEIzi Medical Products, LLCKXK2021-10-15
10801741184120SourceLink™Bard Brachytherapy, Inc.KXK2020-08-06
10801741184137SourceLink™Bard Brachytherapy, Inc.KXK2020-08-06
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
B887MRTL050415200VISICOIL MR Twin LineIzi Medical Products, LLCKXK2020-04-30
B887MRTL050415210VISICOIL MR Twin LineIzi Medical Products, LLCKXK2020-04-30
B887MRTL050820210VISICOIL MR Twin LineIzi Medical Products, LLCKXK2020-04-30
B887MRTL075415190VISICOIL MR Twin LineIzi Medical Products, LLCKXK2020-04-30
B887MRTL075820190VISICOIL MR Twin LineIzi Medical Products, LLCKXK2020-04-30
B887MRTLS075920180VISICOIL MR Twin LineIzi Medical Products, LLCKXK2020-04-30
B887PTTL050110210VISICOIL MR Twin LineIzi Medical Products, LLCKXK2020-04-30
B887TL050215200VISICOILIzi Medical Products, LLCKXK2020-04-30