GammaTile

GUDID 20860000064549

Preloaded flexible braided strands with Cs-131 Brachytherapy seeds inside a purified collagen carrier

GT MEDICAL TECHNOLOGIES, INC.

Manual brachytherapy source, permanent implant Manual brachytherapy source, permanent implant Manual brachytherapy source, permanent implant Manual brachytherapy source, permanent implant Manual brachytherapy source, permanent implant Manual brachytherapy source, permanent implant Manual brachytherapy source, permanent implant Manual brachytherapy source, permanent implant Manual brachytherapy source, permanent implant Manual brachytherapy source, permanent implant Manual brachytherapy source, permanent implant
Primary Device ID20860000064549
NIH Device Record Keyd4fbbf49-c9eb-4f61-9cee-d7288dbf9409
Commercial Distribution StatusIn Commercial Distribution
Brand NameGammaTile
Version Model NumberGT-001
Company DUNS081299204
Company NameGT MEDICAL TECHNOLOGIES, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100860000064545 [Primary]
GS110860000064542 [Package]
Contains: 00860000064545
Package: Inner Pack [1 Units]
In Commercial Distribution
GS120860000064549 [Package]
Contains: 00860000064545
Package: Inner Pack [2 Units]
In Commercial Distribution
GS130860000064546 [Package]
Contains: 00860000064545
Package: Inner Pack [3 Units]
In Commercial Distribution
GS140860000064543 [Package]
Contains: 00860000064545
Package: Inner Pack [4 Units]
In Commercial Distribution
GS150860000064540 [Package]
Contains: 00860000064545
Package: Inner Pack [5 Units]
In Commercial Distribution
GS160860000064547 [Package]
Contains: 00860000064545
Package: Inner Pack [6 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KXKSource, Brachytherapy, Radionuclide

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-05-07
Device Publish Date2024-04-29

Devices Manufactured by GT MEDICAL TECHNOLOGIES, INC.

20860000064549 - GammaTile2024-05-07Preloaded flexible braided strands with Cs-131 Brachytherapy seeds inside a purified collagen carrier
20860000064549 - GammaTile2024-05-07 Preloaded flexible braided strands with Cs-131 Brachytherapy seeds inside a purified collagen carrier
00860000064569 - CS-12024-05-07
00860000064576 - CS-12024-05-07
00860000064583 - PL-12024-05-07
00860000064590 - PL-52024-05-07
00860011485407 - PL-22024-05-07
00860011485414 - PL-32024-05-07
00860011485421 - PL-42024-05-07

Trademark Results [GammaTile]

Mark Image

Registration | Serial
Company
Trademark
Application Date
GAMMATILE
GAMMATILE
88226299 not registered Live/Pending
GT MEDICAL TECHNOLOGIES, INC.
2018-12-12
GAMMATILE
GAMMATILE
86570994 not registered Dead/Abandoned
GT MEDICAL TECHNOLOGIES, INC.
2015-03-20
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.