Home GUDID 03662200013296 NOVAE
Primary DI 03662200013296
Brand NOVAE
Company SOC ETUDES RECHERCHES FABRICATION
Model PC-49
Published 2022-12-09
Public version status New
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 03662200013296 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 03662200013296 03662200013296 3662200013296
GMDN Terms# Term, Definition table Term Definition Surgical implant/trial-implant/sizer holder, reusable A hand-held manual surgical instrument designed to connect to and hold an implant (e.g., bone screw, bone graft), trial implant, or implantable device sizer/template (e.g., glenoid defect sizer, hearing implant template) to facilitate guidance, gauging/sizing, and/or monitoring of the held device during orthopaedic or ear/nose/throat (ENT) surgery. The instrument is typically made of metal or synthetic polymer materials and is typically constructed in the form of a long shaft with a handle at the proximal end and a device holding/fixation mechanism at the distal end. This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 282651413 Device count 1 DM exempt true 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#