Home GUDID 03662200020478
NOVAE
Primary DI 03662200020478
Brand NOVAE
Company SOC ETUDES RECHERCHES FABRICATION
Model EI045
Published 2024-02-09
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name LXH Orthopedic Manual Surgical Instrument
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LXH Orthopedic Manual Surgical Instrument Orthopedic 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 03662200020478 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 03662200020478 03662200020478 3662200020478
GMDN Terms# Term, Definition table Term Definition Orthopaedic implant impactor, reusable A metal and/or plastic hand-held manual surgical instrument designed to position an orthopaedic implant within the body by transmission of an impact force that drives the implant into its final position. The proximal end of the instrument is a handle usually designed to absorb the impact from a surgical hammer or mallet, and the distal end is usually shaped to conform to the implant shape (flat or anatomically curved) or is shaped like a chisel handle to facilitate implant positioning. This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 282651413 Device count 1 Premarket exempt true Lot or batch true Manufacturing date on label true Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 03662200033126 Trays associated with hip instruments RA99990062 2024-09-17 03662200005796 CI E CI 41/22,2 E 2015-09-01 03662200005802 CI E CI 43/22,2 E 2015-09-01 03662200005819 CI E CI 45/22,2 E 2015-09-01 03662200005826 CI E CI 47/22,2 E 2015-09-01 03662200005833 CI E CI 49/22,2 E 2015-09-01 03662200005840 CI E CI 51/22,2 E 2015-09-01 03662200005857 CI E CI 53/22,2 E 2015-09-01 03662200005864 CI E CI 55/22,2 E 2015-09-01 03662200005871 CI E CI 57/22,2 E 2015-09-01 03662200005888 CI E CI 59/22,2 E 2015-09-01 03662200005895 CI E CI 61/22,2 E 2015-09-01 03662200005901 CI E CI 63/22,2 E 2015-09-01 03662200005918 CI E CI 65/22,2 E 2015-09-01 03662200005925 CI E CI 67/22,2 E 2015-09-01 03662200005932 CI E CI 69/22,2 E 2015-09-01 03662200005963 CI E CI 47/28 E 2015-09-01 03662200005970 CI E CI 49/28 E 2015-09-01 03662200005987 CI E CI 51/28 E 2015-09-01 03662200005994 CI E CI 53/28 E 2015-09-01
Other Devices Sharing Product Codes#