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 Prostate brachytherapy system applicator, manual Prostate brachytherapy system applicator, manual Prostate brachytherapy system applicator, manual Prostate brachytherapy system applicator, manual Prostate brachytherapy system applicator, manual Prostate brachytherapy system applicator, manual Prostate brachytherapy system applicator, manual Prostate brachytherapy system applicator, manual Prostate brachytherapy system applicator, manual Prostate brachytherapy system applicator, manual

Primary Device ID	00860011485469
NIH Device Record Key	d0df2dd4-174a-46a5-bb11-945b52e0ee5a
Commercial Distribution Status	In Commercial Distribution
Brand Name	PL-8
Version Model Number	PL-8
Company DUNS	081299204
Company Name	GT MEDICAL TECHNOLOGIES, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Conditional
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860011485469 [Primary]
HIBCC	M748PL80 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K202267

FDA Product Code

KXK	Source, Brachytherapy, Radionuclide

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2024-05-07
Device Publish Date	2024-04-29

Devices Manufactured by GT MEDICAL TECHNOLOGIES, INC.

20860000064549 - GammaTile	2024-05-07 Preloaded flexible braided strands with Cs-131 Brachytherapy seeds inside a purified collagen carrier
00860000064569 - CS-1	2024-05-07
00860000064576 - CS-1	2024-05-07
00860000064583 - PL-1	2024-05-07
00860000064590 - PL-5	2024-05-07
00860011485407 - PL-2	2024-05-07
00860011485414 - PL-3	2024-05-07
00860011485421 - PL-4	2024-05-07