Home GUDID M368136302
LUMEX
Primary DI M368136302
Brand LUMEX
Company GF HEALTH PRODUCTS, INC.
Model 13630
Device description Pocket Goniometer
Published 2020-09-09
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile false
Single use false
Product Codes# Code, Name table Code Name FTY Tape, Measuring, Rulers And Calipers KQW Goniometer, Nonpowered
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FTY Tape, Measuring, Rulers And Calipers General, Plastic Surgery 1 KQW Goniometer, Nonpowered Orthopedic 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status M368136302 Package HIBCC 400 In Commercial Distribution M368136301 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Manual goniometer A non-powered, manually-operated measuring device, graduated in degrees (e.g., from 0 to 360 degrees), designed to be used in a clinical setting to measure the range of motion of the limb of a patient by measuring the angle of movement achieved at the joint. It is typically used by rheumatologists, physiotherapists, orthopaedists and general practitioners to evaluate joint movement (e.g., ankle, finger, knee, shoulder or spine) before and after a medical/surgical intervention. It may be made of plastic or stainless steel and is available in various designs (e.g., protractor-like with pivoting arms, dial-like with twin rotating dials). This is a reusable device.
Regulatory Flags# DUNS number 132016168 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 false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 08809513720069 SAEHAN Skinfold Caliper Saehan Corporation FTY 2026-05-18 00850085914002 IMRISeye IMRIS Imaging, Inc. FTY 2026-05-07 G4250010 My Medical My Medical Store LLC FTY 2026-05-04 G4250020 My Medical My Medical Store LLC FTY 2026-05-04 00190776418724 Millennium Avalign Technologies, Inc. FTY 2026-04-09 00757770413607 Bausch + Lomb Bausch & Lomb Incorporated FTY 2026-03-31 00840117349827 Durma+ DynaRule Disposable Paper Rulers Dynarex Corporation FTY 2026-03-24 00842071152956 AMT Balloon Measuring Device APPLIED MEDICAL TECHNOLOGY, INC. FTY 2026-02-20 00887868287510 Trinica ALP Anterior Lumbar Plate System Highridge Medical, LLC FTY 2025-11-12 03662663108027 Trinica/Trinica Select Anterior Cervical Plate System Highridge Medical, LLC FTY 2025-11-12 03662663108034 Trinica/Trinica Select Anterior Cervical Plate System Highridge Medical, LLC FTY 2025-11-12 03662663108041 Trinica/Trinica Select Anterior Cervical Plate System Highridge Medical, LLC FTY 2025-11-12 08809986680198 Magic Ruler InnoBioSurg Co.,Ltd(IBS implant Co.,Ltd) FTY 2025-10-30 09348215165192 Tendon Ruler SIGNATURE ORTHOPAEDICS PTY LTD FTY 2025-10-10 G79151202DMD000G0 WishFIX Red Star Contract Manufacturing Inc. FTY 2025-10-06 00371347019841 Advance Dental Products The Atlanta Dental Supply Company FTY 2025-10-02 10197344154654 MEDLINE MEDLINE INDUSTRIES, INC. FTY 2025-07-28 14026704920553 KMEDIC TELEFLEX INCORPORATED FTY 2024-07-15 14026704920560 KMEDIC TELEFLEX INCORPORATED FTY 2024-07-15 14026704920577 KMEDIC TELEFLEX INCORPORATED FTY 2024-07-15 14026704920584 KMEDIC TELEFLEX INCORPORATED FTY 2024-07-15 14026704920805 KMEDIC TELEFLEX INCORPORATED FTY 2024-07-15 14026704920812 KMEDIC TELEFLEX INCORPORATED FTY 2024-07-15 14026704921086 KMEDIC TELEFLEX INCORPORATED FTY 2024-07-15 00190707105693 Carriere InfiNiTi Loops Ortho Organizers, Inc. FTY 2024-03-01 00190707103194 Carriere® Motion Pro™ Ortho Organizers, Inc. FTY 2024-01-16 00630094177724 Bioseal Inc. BIOSEAL FTY 2023-10-05 00630094177885 Bioseal Inc. BIOSEAL FTY 2023-10-05 00630094177175 Bioseal Inc. BIOSEAL FTY 2023-10-03 00630094177205 Bioseal Inc. BIOSEAL FTY 2023-10-03