FDA.reportPublic FDA data

GammaTile

Primary DI
20860000064549
Brand
GammaTile
Company
GT MEDICAL TECHNOLOGIES, INC.
Model
GT-001
Device description
Preloaded flexible braided strands with Cs-131 Brachytherapy seeds inside a purified collagen carrier
Published
2024-04-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
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
K221539000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221539000GammaTileGt Medical Technologies2022-11-09KXK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10860000064542PackageGS11In Commercial Distribution
20860000064549PackageGS12In Commercial Distribution
30860000064546PackageGS13In Commercial Distribution
40860000064543PackageGS14In Commercial Distribution
50860000064540PackageGS15In Commercial Distribution
60860000064547PackageGS16In Commercial Distribution
00860000064545PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086000006454210860000064542
2086000006454920860000064549
3086000006454630860000064546
4086000006454340860000064543
5086000006454050860000064540
6086000006454760860000064547
00860000064545008600000645458600000645450860000064545

GMDN Terms#

Term, Definition table
TermDefinition
Manual brachytherapy source, permanent implantA device that is a naturally-occurring, accelerator- or reactor-produced radioactive isotope and intended to be permanently implanted into the body in order to deliver curative or palliative radiotherapy treatments. It is typically placed in the body by means of an applicator using either fluoroscopic or endoscopic guidance. Manually implanted sources intended for permanent implantation are designed to be histocompatible. It may take the form of, e.g., microspheres, spheres, stents, seeds or wires selected for producing low energy photons, beta or alpha particles.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
081299204
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
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860011485452PL-7PL-72024-04-29
00860011485469PL-8PL-82024-04-29
00860000064545GammaTileGT-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
M936PDIS4721IsoSphereISOAID, L.L.C.KXK2026-05-12
00841365121531Best Medical InternationalBEST MEDICAL INTERNATIONAL, INC.KXK2026-05-04
00841365121500Best Medical InternationalBEST MEDICAL INTERNATIONAL, INC.KXK2026-04-03
00841365121425Best Medical InternationalBEST MEDICAL INTERNATIONAL, INC.KXK2025-12-16
00841365121388Best Medical InternationalBEST MEDICAL INTERNATIONAL, INC.KXK2025-10-20
M936IRLS15SSS9Advantage I-125ISOAID, L.L.C.KXK2025-03-04
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
00860000064545GammaTileGT 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
00850800006067VariSeedVARIAN MEDICAL SYSTEMS, INC.KXK2023-09-15
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 LineIzi Medical Products, LLCKXK2022-06-03
B887MRTLS075515180VISICOIL MR Twin LineIzi Medical Products, LLCKXK2022-06-03