Home GUDID H679395490 NA
Primary DI H679395490
Brand NA
Company Synthes GmbH
Model 395.49
Catalog number 39549
Device description MEDIUM DISTRACTOR
Published 2016-12-31
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name HST APPARATUS, TRACTION, NON-POWERED
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HST Apparatus, Traction, Non-Powered Orthopedic 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10886982200341 Primary GS1 0 H679395490 Secondary HIBCC 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 10886982200341 10886982200341
GMDN Terms# Term, Definition table Term Definition Orthopaedic surgical distractor, internal A hand-held manual surgical instrument designed to invasively distract (force apart) two bone surfaces to enable a surgical procedure. It typically aids in fracture reduction by helping to temporarily stabilize bones prior to definitive surgical fixation. It typically consists of a central threaded spindle, a static endpiece and a sliding carriage that can be adjusted using spindle nuts to/from the endpiece to widen or shorten the gap; it facilitates the attachment of orthopaedic bone pins (Schanz screws) screwed into the bones to be distracted. It is typically used for multiple injuries when it is advantageous to perform procedures on a standard operating table. This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 486711679 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false 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 00190776415174 Millennium Avalign Technologies, Inc. HST 2025-12-03 00842430116728 TRAPEZE ARM ASSEMBLY, PATIENT HELPER MIZUHO ORTHOPEDIC SYSTEMS, INC. HST 2025-07-28 00887482122723 Symmetry Logan ASPEN SURGICAL PRODUCTS, INC. HST 2024-08-20 00615521004712 Arthrex ALLEN MEDICAL SYSTEMS, INC. HST 2024-05-23 00615521004736 Arthrex ALLEN MEDICAL SYSTEMS, INC. HST 2024-05-23 00615521004750 Arthrex ALLEN MEDICAL SYSTEMS, INC. HST 2024-05-23 00615521004828 Arthrex ALLEN MEDICAL SYSTEMS, INC. HST 2024-05-23 00615521004842 Arthrex ALLEN MEDICAL SYSTEMS, INC. HST 2024-05-23 00840277130495 Innomed, Inc. INNOMED, INC. HST 2024-05-09 00860011457800 IHN IHN, Inc. HST 2024-02-07 00860011457817 IHN IHN, Inc. HST 2024-02-07 10860011457807 IHN IHN, Inc. HST 2024-02-07 10860011457814 IHN IHN, Inc. HST 2024-02-07 00840277129444 Innomed,Inc. INNOMED, INC. HST 2023-12-19 00840277129451 Innomed, Inc. INNOMED, INC. HST 2023-12-19 00840277129468 Innomed,Inc. INNOMED, INC. HST 2023-12-19 00840277129475 Innomed, Inc. INNOMED, INC. HST 2023-12-19 00840277129482 Innomed, Inc. INNOMED, INC. HST 2023-12-19 00840277129499 Innomed, Inc. INNOMED, INC. HST 2023-12-19 00724995225544 NA STERIS CORPORATION HST 2023-11-17 00860011173618 AFT HILL LABORATORIES CO. HST 2023-10-23 00860011173625 Air Drop AFT HILL LABORATORIES CO. HST 2023-10-23 00860001452570 Air Flex II HILL LABORATORIES CO. HST 2023-10-16 04719871180167 EVERYWAY4ALL EVERYWAY MEDICAL INSTRUMENTS CO., LTD. HST 2023-08-24 04719871180365 EVERYWAY4ALL EVERYWAY MEDICAL INSTRUMENTS CO., LTD. HST 2023-08-24 00615521001490 ALLEN HILL-ROM, INC. HST 2023-07-31 00615521001506 ALLEN HILL-ROM, INC. HST 2023-07-31 00615521012823 ALLEN HILL-ROM, INC. HST 2023-07-31 00615521021160 ALLEN HILL-ROM, INC. HST 2023-07-31 00615521021177 ALLEN HILL-ROM, INC. HST 2023-07-31
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