Home GUDID 10197344044795 MEDLINE
Primary DI 10197344044795
Brand MEDLINE
Company MEDLINE INDUSTRIES, INC.
Model ESE103A
Catalog number ESE103A
Device description TIP NEEDLE 3CM 3/32 SLEEVE
Published 2025-09-23
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
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 20197344044792 Package GS1 10 In Commercial Distribution 10197344044795 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 20197344044792 20197344044792 10197344044795 10197344044795
GMDN Terms# Term, Definition table Term Definition Needle guide, single-use A rigid, non-powered device designed to direct a sharp 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 different procedures such as urethral injections, image-guided (e.g., ultrasound, MRI) transrectal/transperineal prostate biopsy or ablation, endocavity IVF procedures, percutaneous punctures, nerve blocks, electromagnetic device tracking surgery, and stereotactic breast biopsies. Procedural supportive devices (e.g., ultrasound transducer cover/sheath, drape) may be included with the device. This is a single-use device.
Regulatory Flags# DUNS number 025460908 Device count 1 Premarket exempt true Lot or batch true Expiration date on label true No natural rubber latex 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 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 10840199505859 Needle Holder KOROS U.S.A., INC. GDF 2022-04-01
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