Home GUDID 25420045514079 PERL
Primary DI 25420045514079
Brand PERL
Company Hologic, Inc.
Model R10-5
Catalog number R10-5
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 25420045514079 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 25420045514079 25420045514079
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 00850084501012 Xpansion® Micro-Autografting Kit NEW HORIZON HEALTHCARE MANAGEMENT LLC GDF 2026-07-28 06976712970334 Hemo Needle Micro-Energy Medical Technology Co., Ltd GDF 2026-07-13 04048223069738 TunnEler 235 Pajunk GmbH Medizintechnologie GDF 2026-06-10 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 08056138586338 MarkX M.D.L. S.R.L. GDF 2025-02-28 08057276004715 MarkX M.D.L. S.R.L. GDF 2025-02-28 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 10840199505767 Needle Holder KOROS U.S.A., INC. GDF 2022-04-01 10840199505774 Needle Holder KOROS U.S.A., INC. GDF 2022-04-01 10840199505798 Needle Holder KOROS U.S.A., INC. GDF 2022-04-01 10840199505804 Needle Holder KOROS U.S.A., INC. GDF 2022-04-01 10840199505811 Needle Holder KOROS U.S.A., INC. GDF 2022-04-01 10840199505828 Needle Holder KOROS U.S.A., INC. GDF 2022-04-01 10840199505835 Needle Holder KOROS U.S.A., INC. GDF 2022-04-01 10840199505842 Needle Holder KOROS U.S.A., INC. GDF 2022-04-01
hologic.com