GammaTile™

GUDID 60860000064509

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

GT MEDICAL TECHNOLOGIES, INC.

Manual brachytherapy source, permanent implant
Primary Device ID60860000064509
NIH Device Record Key81dc6a43-b90f-4e91-af15-d412c3d00ba1
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

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.

Device Identifiers

Device Issuing AgencyDevice ID
GS100860000064507 [Primary]
GS110860000064504 [Package]
Contains: 00860000064507
Package: outer pouch [1 Units]
In Commercial Distribution
GS120860000064501 [Package]
Contains: 00860000064507
Package: outer pouch [2 Units]
In Commercial Distribution
GS130860000064508 [Package]
Contains: 00860000064507
Package: Outer Pouch [3 Units]
In Commercial Distribution
GS140860000064505 [Package]
Contains: 00860000064507
Package: outer pouch [4 Units]
In Commercial Distribution
GS150860000064502 [Package]
Contains: 00860000064507
Package: outer pouch [5 Units]
In Commercial Distribution
GS160860000064509 [Package]
Contains: 00860000064507
Package: Outer Pouch [6 Units]
In Commercial Distribution

FDA Product Code

KXKSource, Brachytherapy, Radionuclide

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-02-06
Device Publish Date2018-09-01

Devices Manufactured by GT MEDICAL TECHNOLOGIES, INC.

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

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