Home GUDID 03662200020508 HYPE stem
Primary DI 03662200020508
Brand HYPE stem
Company SOC ETUDES RECHERCHES FABRICATION
Model RH606 2
Published 2024-02-16
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 03662200020508 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 03662200020508 03662200020508 3662200020508
GMDN Terms# Term, Definition table Term Definition Orthopaedic prosthesis implantation positioning 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 [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prostheses, or prosthesis components; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) 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 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
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