Home GUDID 00841013120480 Otto Leibinger
Primary DI 00841013120480
Brand Otto Leibinger
Company AMERICAN EAGLE INSTRUMENTS, INC.
Model AESSH5
Device description Scalpel Handle, ergonomic
Published 2026-01-06
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name GDZ Handle, Scalpel
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GDZ Handle, Scalpel General, Plastic Surgery 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00841013120480 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 00841013120480 00841013120480 841013120480 0841013120480
GMDN Terms# Term, Definition table Term Definition Scalpel handle, reusable A device that is an interchangeable component of a scalpel and that functions as a handle designed to mount a compatible blade. This device with the blade become a single-bladed surgical instrument intended to be used by a physician for cutting or dissecting tissue. The device is typically made of metal (e.g., stainless steel or brass). This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 790776850 Device count 1 Premarket exempt true Lot or batch true Manufacturing date on label true Sterilization required before use true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00810055257348 Surgical Design Surgical Design, Inc. GDZ 2026-05-29 00810055257355 Surgical Design Surgical Design, Inc. GDZ 2026-05-29 00810055257362 Surgical Design Surgical Design, Inc. GDZ 2026-05-29 00810055257379 Surgical Design Surgical Design, Inc. GDZ 2026-05-29 00810055257386 Surgical Design Surgical Design, Inc. GDZ 2026-05-29 00810055257850 Surgical Design Surgical Design, Inc. GDZ 2026-05-29 00190776421533 Millennium Avalign Technologies, Inc. GDZ 2026-05-05 00190776419769 Millennium Avalign Technologies, Inc. GDZ 2026-04-15 00190776419776 Millennium Avalign Technologies, Inc. GDZ 2026-04-15 00190776419783 Millennium Avalign Technologies, Inc. GDZ 2026-04-15 00190776418410 Millennium Avalign Technologies, Inc. GDZ 2026-03-25 09348811000040 INKA The Trustee for KAISER FAMILY TRUST GDZ 2025-11-19 B382SD9045551000 Surgical Direct Surgical Direct, Inc. GDZ 2025-09-10 B382SD9045551010 Surgical Direct Surgical Direct, Inc. GDZ 2025-09-10 B382SD9045551020 Surgical Direct Surgical Direct, Inc. GDZ 2025-09-10 B382SD9045551030 Surgical Direct Surgical Direct, Inc. GDZ 2025-09-10 16945630137621 index Asurity Sterilance Medical (Suzhou) Inc. GDZ 2025-08-25 16945630137638 index Asurity Sterilance Medical (Suzhou) Inc. GDZ 2025-08-25 38886354702639 Anzen Safety Scalpel MEDIPURPOSE PTE. LTD. GDZ 2025-02-12 B382SD904320210 Surgical Direct Surgical Direct, Inc. GDZ 2024-07-11 M944AL019130 Wexler Surgical, Inc. WEXLER SURGICAL, INC. GDZ 2024-02-12 M944AL019230 Wexler Surgical, Inc. WEXLER SURGICAL, INC. GDZ 2024-02-12 14026704922991 PILLING TELEFLEX INCORPORATED GDZ 2023-11-07 10620974003318 SPSS Safety Scalpel Metal Handle Southmedic Incorporated GDZ 2023-02-07 10620974003325 SPSS Safety Scalpel Metal Handle Southmedic Incorporated GDZ 2023-02-07 10620974003332 SPSS Safety Scalpel Metal Handle Southmedic Incorporated GDZ 2023-02-07 10620974003349 SPSS Safety Scalpel Metal Handle Southmedic Incorporated GDZ 2023-02-07 10620974003356 SPSS Safety Scalpel Metal Handle Southmedic Incorporated GDZ 2023-02-07 G25001001030 Scalpel Handle No.3 N S SURGICAL COMPANY GDZ 2023-01-31 G25001002040 Scalpel Handle No.4 N S SURGICAL COMPANY GDZ 2023-01-31