Home GUDID 15420045514096 PERL
Primary DI 15420045514096
Brand PERL
Company Hologic, Inc.
Model R20
Catalog number R20
Device description Perl Ring Localization Device
Published 2021-09-17
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 25420045514123 Package GS1 5 In Commercial Distribution 15420045514096 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 25420045514123 25420045514123 15420045514096 15420045514096
GMDN Terms# Term, Definition table Term Definition Nonimplantable needle guide, single-use A rigid, non-powered device designed to lead a needle (not included) into its proper course when performing a clinical and/or surgical procedure; the guide itself is not intended for percutaneous access (not a guide-catheter). Dedicated needle guides are available for many different procedures such as guides for urethral injections, guides for transrectal prostate biopsy, image-guided (e.g., ultrasound, MRI) for percutaneous punctures and nerve blocks, guides for electromagnetic device tracking systems, and guides for stereotactic breast biopsies. Disposable imaging-supportive devices (e.g., ultrasound transducer cover/gel) may be included with the device. This is a single-use device.
Regulatory Flags# DUNS number 018925968 Device count 1 DM exempt true 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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