PL-3

GUDID 00860011485414

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 ID00860011485414
NIH Device Record Key3f78fb8e-a58e-431e-8ba8-f3f8e7ffa2df
Commercial Distribution StatusIn Commercial Distribution
Brand NamePL-3
Version Model NumberPL-3
Company DUNS081299204
Company NameGT MEDICAL TECHNOLOGIES, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
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
GS100860011485414 [Primary]
HIBCCM748PL30 [Previous]

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 - GammaTile2024-05-07 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
00860011485414 - PL-32024-05-07
00860011485421 - PL-42024-05-07
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