Home GUDID EMAHCHM01100 Set screw w.plate f.polyaxial screws
Primary DI EMAHCHM01100
Brand Set screw w.plate f.polyaxial screws
Company mahe medical gmbh
Model CHM01-10
Catalog number CHM01-10
Device description Set screw w.plate f.polyaxial screws
Published 2016-07-05
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true Product Codes# Code, Name table Code Name NKB Orthosis, spinal pedicle fixation, for degenerative disc disease
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class NKB Thoracolumbosacral Pedicle Screw System Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status EMAHCHM01101 Package HIBCC 1 In Commercial Distribution EMAHCHM01100 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Bone-screw internal spinal fixation system, non-sterile An assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included.
Device Sizes# Type, Value, Unit table Type Value Unit Width 6.6 Millimeter
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 cool, dry, dark Storage Environment Humidity 10 Percent (%) Relative Humidity 50 Percent (%) Relative Humidity Storage Environment Temperature 10 Degrees Celsius 28 Degrees Celsius
Regulatory Flags# DUNS number 342243334 Device count 1 Kit true Lot or batch true No natural rubber latex true 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 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 EMAHPSS0845450 Polyaxial screw, w/o cannulation, 4.5mm/45mm PSS08-4545 PSS08-4545 2016-07-06
Other Devices Sharing Product Codes# 
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