Home GUDID EMAH1506635042PTXL1 TI 3.5mm mono-/polyaxial locking screw, L.42mm
Primary DI EMAH1506635042PTXL1
Brand TI 3.5mm mono-/polyaxial locking screw, L.42mm
Company mahe medical gmbh
Model 150-6635-042PTXL
Catalog number 150-6635-042PTXL
Device description TI 3.5mm mono-/polyaxial locking screw, L.42mm
Published 2016-08-02
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 true Product Codes# Code, Name table Code Name HWC Screw, fixation, bone
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HWC Screw, Fixation, Bone Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status EMAH1506635042PTXL1 Package HIBCC 1 In Commercial Distribution EMAH1506635042PTXL0 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Orthopaedic bone screw, non-bioabsorbable, non-sterile A small, non-sterile, threaded rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that cannot be chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). Screws available are: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded, self-tapping, and cannulated. A "lag screw" can be any of these used to obtain compression. This device must be sterilized prior to use.
Device Sizes# Type, Value, Unit table Type Value Unit Outer Diameter 3.5 Millimeter
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Humidity 10 Percent (%) Relative Humidity 50 Percent (%) Relative Humidity
Regulatory Flags# DUNS number 342243334 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label true Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex true Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published EMAHKM714590 Steinmann pin w. double end trocarpoint 3.2mm/229mm, 6 pcs./unit KM71-459 KM71-459 2016-06-13 EMAHKM715100 Steinmann pin w. trocar/round end 2.0mm/229mm, 6 pcs./unit KM71-510 KM71-510 2016-04-28 EMAHKM715130 Steinmann pin w. trocar/round end 2.4mm/229mm, 6 pcs./unit KM71-513 KM71-513 2016-04-28 EMAHKM718800 Steinmann pin 3 Shank End, Diamond Point 2.0mm/229mm, Sutur Passer KM71-880 KM71-880 2016-06-10 04050659210974 mahe medical GmbH 004-80009 2019-11-05 04050659484832 mahe medical GmbH KM71-459 2019-11-05 04050659484948 mahe medical GmbH KM71-510 2019-11-05 04050659484955 mahe medical GmbH KM71-513 2019-11-05 04050659485228 mahe medical GmbH KM71-675 2019-11-05 04050659485600 mahe medical GmbH KM71-880 2019-11-05 EMAHCHM01100 Set screw w.plate f.polyaxial screws CHM01-10 CHM01-10 2016-07-05 EMAHCHM01110 Set screw f.polyaxial screws CHM01-11 CHM01-11 2016-07-05 EMAHPSR1175450 Polyaxial screw reduct., w/o cannulation 7.5mm/45mm PSR11-7545 PSR11-7545 2016-08-04 EMAHPSR1175500 Polyaxial screw reduct., w/o cannulation 7.5mm/50mm PSR11-7550 PSR11-7550 2016-08-04 EMAHPSR1175550 Polyaxial screw reduct., w/o cannulation 7.5mm/55mm PSR11-7555 PSR11-7555 2016-08-04 EMAHPSR1175600 Polyaxial screw reduct., w/o cannulation 7.5mm/60mm PSR11-7560 PSR11-7560 2016-08-04 EMAHPSS0845250 Polyaxial screw, w/o cannulation, 4.5mm/25mm PSS08-4525 PSS08-4525 2016-07-05 EMAHPSS0845300 Polyaxial screw, w/o cannulation, 4.5mm/30mm PSS08-4530 PSS08-4530 2016-07-06 EMAHPSS0845350 Polyaxial screw, w/o cannulation, 4.5mm/35mm PSS08-4535 PSS08-4535 2016-07-06 EMAHPSS0845400 Polyaxial screw, w/o cannulation, 4.5mm/40mm PSS08-4540 PSS08-4540 2016-07-06
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