PL-8

GUDID 00860011485469

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.

GT MEDICAL TECHNOLOGIES, INC.

Prostate brachytherapy system applicator, manual
Primary Device ID00860011485469
NIH Device Record Keyd0df2dd4-174a-46a5-bb11-945b52e0ee5a
Commercial Distribution StatusIn Commercial Distribution
Brand NamePL-8
Version Model NumberPL-8
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
GS100860011485469 [Primary]
HIBCCM748PL80 [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
00860011485421 - PL-42024-05-07
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