PL-4NS

GUDID 00860011485438

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 ID00860011485438
NIH Device Record Key6747fe21-a3eb-4fc2-8d3d-a3db3f367a87
Commercial Distribution StatusIn Commercial Distribution
Brand NamePL-4NS
Version Model NumberPL-4NS
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
GS100860011485438 [Primary]
HIBCCM748PL4NS0 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KXKSource, Brachytherapy, Radionuclide

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00860011485438]

Moist Heat or Steam Sterilization

[00860011485438]

Moist Heat or Steam Sterilization

[00860011485438]

Moist Heat or Steam Sterilization

[00860011485438]

Moist Heat or Steam Sterilization

[00860011485438]

Moist Heat or Steam Sterilization

[00860011485438]

Moist Heat or Steam Sterilization

[00860011485438]

Moist Heat or Steam Sterilization

[00860011485438]

Moist Heat or Steam Sterilization

[00860011485438]

Moist Heat or Steam Sterilization

[00860011485438]

Moist Heat or Steam Sterilization

[00860011485438]

Moist Heat or Steam Sterilization

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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