Home GUDID 04260148895074 HPS Sterilization container 1
Primary DI 04260148895074
Brand HPS Sterilization container 1
Company Paradigm Spine, LLC
Model HAC00001
Published 2017-10-24
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 FSM Tray, Surgical, Instrument
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FSM Tray, Surgical, Instrument General, Plastic Surgery 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 04260148895074 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 04260148895074 04260148895074 4260148895074
GMDN Terms# Term, Definition table Term Definition Orthopaedic prosthesis implantation instrument, reusable A hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments. It may be used for the following applications: 1) to hold/align/fix bone preparation instruments, prosthesis, or prosthesis component; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface between prosthesis components. This is a reusable device intended to be sterilized prior to use.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 787874960 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 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# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 04260148898235 CoFix Implant 8 mm RQI00008 RQI00008 2020-03-19 04260148898242 CoFix Implant 10 mm RQI00010 RQI00010 2020-03-19 04260148898259 CoFix Implant 12 mm RQI00012 RQI00012 2020-03-19 04260148898266 CoFix Implant 14 mm RQI00014 RQI00014 2020-03-19 04260148898273 CoFix Implant 16 mm RQI00016 RQI00016 2020-03-19 04260148897931 CoFix Sterilization Tray RAC10000 2020-03-04 04260636670459 coflex-F LIS screw inserter RAT20222 2020-03-04 04260148896927 DSS HP Polyaxial pedicle screw set, Ø5 x 45mm HPI85045 2015-10-01 04260148897825 coflex crimping pliers, long UAT10250 2018-10-23 04260148897849 coflex dual pliers UAT10260 2018-10-10 04260148894282 DSS Pedicle Screw Set, Ø5.0 x 60mm DPI55060 2018-08-03 04260148894299 DSS Pedicle Screw Set, Ø6.0 x 60mm DPI56060 2018-08-03 04260148894305 DSS Pedicle Screw Set, Ø7.0 x 60mm DPI57060 2018-08-03 04260148897856 coflex Mallet UAT20120 2018-08-02 04260148897863 coflex mallet cap UAT20130 2018-08-02 04260148897740 coflex trial with guide and x-ray marker, 8mm UXT10008 2018-06-28 04260148897757 coflex trial with guide and x-ray marker, 10mm UXT10010 2018-06-28 04260148897764 coflex trial with guide and x-ray marker, 12mm UXT10012 2018-06-28 04260148897771 coflex trial with guide and x-ray marker, 14mm UXT10014 2018-06-28 04260148897788 coflex trial with guide and x-ray marker, 16mm UXT10016 2018-06-28
Other Devices Sharing Product Codes#