Home GUDID 03662200012947 NOVAE
Primary DI 03662200012947
Brand NOVAE
Company SOC ETUDES RECHERCHES FABRICATION
Model ECM 8
Published 2022-12-09
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 03662200012947 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 03662200012947 03662200012947 3662200012947
GMDN Terms# Term, Definition table Term Definition Orthopaedic inorganic implant inserter/extractor, reusable A hand-held manual surgical instrument designed for the surgical insertion and/or extraction of a non-tissue based (inorganic) orthopaedic implant (e.g., a bone nail, spiral blade, or bone fixation plate). It is an instrument in a one-piece or modular configuration with a region that will attach/fit/lock to part of the implant, and typically features either a mechanism to apply a striking force (e.g., on a pad/flange) a mechanism for twisting (screwing) (e.g., T-handle), or a plunger mechanism to deploy a guide to drive the implant into place. 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#