Home GUDID 00840124525528 Handle
Primary DI 00840124525528
Brand Handle
Company FUSION ORTHOPEDICS, LLC
Model TN-HN-6014
Catalog number TN-HN-6014
Device description Non-Ratcheting Alternative
Published 2026-04-09
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 00840124525528 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 00840124525528 00840124525528 840124525528 0840124525528
GMDN Terms# Term, Definition table Term Definition Orthopaedic osteotome handle A hand-held component of an orthopaedic osteotome intended to be attached to an interchangeable blade (not included) to become a chisel-like surgical instrument designed to cut and/or shape bone by percussion during an orthopaedic procedure. The operator holds this part of the instrument and manually imparts a force to it using a surgical mallet or hammer; it is made of metal and/or polymer materials. This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 080307067 Device count 1 DM exempt true Premarket exempt true Lot or batch true Manufacturing date on label true Expiration date on label true Donation ID number 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 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 07708626670395 SAMPEDRO INDUSTRIAS MEDICAS SAMPEDRO S A S GDZ 2023-01-18 B356BH103010 American Medicals American Medicals GDZ 2023-01-02 00386120012230 MYCO MYCO MEDICAL SUPPLIES INC. GDZ 2022-12-09 00386120012247 MYCO MYCO MEDICAL SUPPLIES INC. GDZ 2022-12-09 00386120012254 MYCO MYCO MEDICAL SUPPLIES INC. GDZ 2022-12-09 00386120012261 MYCO MYCO MEDICAL SUPPLIES INC. GDZ 2022-12-09