Home GUDID H98003305500S0 NA
Primary DI H98003305500S0
Brand NA
Company SYNTHES (U.S.A.) LP
Model 03.305.500S
Catalog number 03305500S
Device description MANDIBLE EXTERNAL FIXATOR 500MM ROD KIT-STERILE
Published 2015-09-14
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name MQN EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MQN External Mandibular Fixator And/Or Distractor Dental 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10887587010069 Primary GS1 0 H98003305500S0 Secondary HIBCC 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 10887587010069 10887587010069
GMDN Terms# Term, Definition table Term Definition External orthopaedic fixation system, reusable An assembly of devices designed to stabilize fractured bones, other than those in the vertebral column, to promote treatment and healing. It typically consists of an external plastic and/or metallic fixator (a framework) and other external and/or implantable components such as clamps, rods, rings, cams, bushings, collars, bolts and nuts; it may also include some instrumentation (e.g., screw drivers, wrenches, drills). It is used mainly to help the healing of long bones such as the femur, tibia and humerus, as well as fractures of the wrist, elbow, knee, hip and ankle, joint fusions, and limb lengthening. This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 832637081 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit true Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true 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 00888118112682 LEVEL ONE CMF KLS-Martin L.P. MQN 2018-01-26 00888118113399 DISTRACTION, INTERNAL KLS-Martin L.P. MQN 2018-01-26 00888118113405 DISTRACTION, INTERNAL KLS-Martin L.P. MQN 2018-01-26 00888118113412 DISTRACTION, INTERNAL KLS-Martin L.P. MQN 2018-01-26 00888118113429 DISTRACTION, INTERNAL KLS-Martin L.P. MQN 2018-01-26 00888118113436 DISTRACTION, INTERNAL KLS-Martin L.P. MQN 2018-01-26 00888118113443 DISTRACTION, INTERNAL KLS-Martin L.P. MQN 2018-01-26 00888118108685 LEVEL ONE CMF KLS-Martin L.P. MQN 2017-08-17 00888118104007 DISTRACTION, INTERNAL, STERILE KLS-Martin L.P. MQN 2016-12-16 00888118104014 DISTRACTION, INTERNAL, STERILE KLS-Martin L.P. MQN 2016-12-16 00888118104021 DISTRACTION, INTERNAL, STERILE KLS-Martin L.P. MQN 2016-12-16 00888118104038 DISTRACTION, INTERNAL, STERILE KLS-Martin L.P. MQN 2016-12-16 00888118104045 DISTRACTION, INTERNAL, STERILE KLS-Martin L.P. MQN 2016-12-16 00888118104052 DISTRACTION, INTERNAL, STERILE KLS-Martin L.P. MQN 2016-12-16 00888118105431 DISTRACTION, INTERNAL, STERILE KLS-Martin L.P. MQN 2016-12-16 00888118105554 DISTRACTION, INTERNAL, STERILE KLS-Martin L.P. MQN 2016-12-16 00888118105561 DISTRACTION, INTERNAL, STERILE KLS-Martin L.P. MQN 2016-12-16 10888118104066 DISTRACTION, INTERNAL, STERILE KLS-Martin L.P. MQN 2016-12-16 10888118104073 DISTRACTION, INTERNAL, STERILE KLS-Martin L.P. MQN 2016-12-16 10888118104080 DISTRACTION, INTERNAL, STERILE KLS-Martin L.P. MQN 2016-12-16 10888118104097 DISTRACTION, INTERNAL, STERILE KLS-Martin L.P. MQN 2016-12-16 10888118104103 DISTRACTION, INTERNAL, STERILE KLS-Martin L.P. MQN 2016-12-16 10888118104110 DISTRACTION, INTERNAL, STERILE KLS-Martin L.P. MQN 2016-12-16 00888118006189 LEVEL ONE CMF KLS-Martin L.P. MQN 2016-03-24 00888118006202 LEVEL ONE CMF KLS-Martin L.P. MQN 2016-03-24 00888118006226 LEVEL ONE CMF KLS-Martin L.P. MQN 2016-03-24 00888118007261 LEVEL ONE CMF KLS-Martin L.P. MQN 2016-03-24 00888118007278 LEVEL ONE CMF KLS-Martin L.P. MQN 2016-03-24 00888118032812 LEVEL ONE CMF KLS-Martin L.P. MQN 2016-03-24 00888118037480 LEVEL ONE CMF KLS-Martin L.P. MQN 2016-03-24
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