Home GUDID 00851766006092 PERL Localization Device
Primary DI 00851766006092
Brand PERL Localization Device
Company FOCAL THERAPEUTICS, INC.
Model R2020
Device description PERL Localization Device, 17Ga x 11.5cm Needle
Published 2017-04-05
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety MR Unsafe
Rx true
Sterile true
Single use true Product Codes# Code, Name table Code Name GDF Guide, Needle, Surgical
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GDF Guide, Needle, Surgical General, Plastic Surgery 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10851766006099 Package GS1 5 Not in Commercial Distribution 00851766006092 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 10851766006099 10851766006099 00851766006092 00851766006092 851766006092 0851766006092
GMDN Terms# Term, Definition table Term Definition Radiological image marker, implantable A device intended to be implanted within the body, either temporarily or permanently, to create identifying marks that can be seen on radiographic film or digital images. It is typically in the form of a wire, needle, bead, clip, stent-like tube, washer or fluid, and used to locate and delineate a tumour, lesion, or other site of interest. It is made from materials compatible with the imaging system with which it is intended to be used [e.g., magnetic resonance imaging (MRI), x-ray, or nuclear medicine]; it may be intended for use during radiotherapy procedures.
Device Sizes# Type, Value, Unit table Type Value Unit Device Size Text, specify 0 Device Size Text, specify 0 Needle Gauge 17 Gauge
Regulatory Flags# DUNS number 965352946 Device count 1 Premarket exempt true Lot or batch true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 10197344044795 MEDLINE MEDLINE INDUSTRIES, INC. GDF 2025-09-23 10197344044801 MEDLINE MEDLINE INDUSTRIES, INC. GDF 2025-09-23 ESAM14762481 STOMA® Storz am Mark GmbH GDF 2025-04-30 07630037864523 APTUS Medartis AG GDF 2025-04-08 07630037864547 APTUS Medartis AG GDF 2025-04-08 07630037864561 APTUS Medartis AG GDF 2025-04-08 07630037864585 APTUS Medartis AG GDF 2025-04-08 10197106342312 CARDINAL HEALTH Cardinal Health 200, LLC GDF 2024-04-01 07630037864165 APTUS Medartis AG GDF 2024-03-22 ESAM14755481 STOMA® Storz am Mark GmbH GDF 2023-11-20 ESAM14760481 STOMA® Storz am Mark GmbH GDF 2023-06-05 ESAM14761481 STOMA® Storz am Mark GmbH GDF 2023-06-05 ESAM14750481 STOMA® Storz am Mark GmbH GDF 2022-11-07 ESAM14751481 STOMA® Storz am Mark GmbH GDF 2022-11-07 08033860028596 BIOPSYBELL BIOPSYBELL SRL GDF 2022-09-16 08033860028602 BIOPSYBELL BIOPSYBELL SRL GDF 2022-09-16 08033860030353 BIOPSYBELL BIOPSYBELL SRL GDF 2022-09-16 10840199534132 Needle Holder KOROS U.S.A., INC. GDF 2022-08-01 10840199534149 Needle Holder KOROS U.S.A., INC. GDF 2022-08-01 10840199534156 Needle Holder KOROS U.S.A., INC. GDF 2022-08-01 10840199534163 Needle Holder KOROS U.S.A., INC. GDF 2022-08-01 10840199534170 Needle Holder KOROS U.S.A., INC. GDF 2022-08-01 10840199534187 Needle Holder KOROS U.S.A., INC. GDF 2022-08-01 10840199534194 Needle Holder KOROS U.S.A., INC. GDF 2022-08-01 10840199534200 Needle Holder KOROS U.S.A., INC. GDF 2022-08-01 10840199534217 Needle Holder KOROS U.S.A., INC. GDF 2022-08-01 10840199534224 Needle Holder KOROS U.S.A., INC. GDF 2022-08-01 10840199534231 Needle Holder KOROS U.S.A., INC. GDF 2022-08-01 10840199534248 Needle Holder KOROS U.S.A., INC. GDF 2022-08-01 10840199534255 Needle Holder KOROS U.S.A., INC. GDF 2022-08-01
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