Home GUDID 00850040139488 ALARA® 11 Gauge Access Needle - Diamond Tip
Primary DI 00850040139488
Brand ALARA® 11 Gauge Access Needle - Diamond Tip
Company Surgentec, LLC
Model AAN-09
Published 2025-04-29
Public version status Update
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 00850040139488 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 00850040139488 00850040139488 850040139488 0850040139488
GMDN Terms# Term, Definition table Term Definition Surgical drill guide, single-use A hand-held tubular surgical device designed to simultaneously place, angle, and guide a rotating surgical drill on hard tissue (e.g., bone), and to protect the surrounding soft tissue while the drill is in operation. It may have serrations at its distal end to enable firm placement on hard tissue surfaces (it is not bored into the tissue); it can have a handle at its proximal end for holding and manipulation, or it may be held by another device (e.g., orthopaedic jig). The device is typically dedicated to drill bit size, made of metal, and may have graduations along its length; it is not custom-made for a specific patient. This is a single-use device.
Regulatory Flags# DUNS number 004095409 Device count 1 Premarket exempt true Lot or batch true Manufacturing date on label 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 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 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