Home GUDID 00846832086504 Tornier Perform
Primary DI 00846832086504
Brand Tornier Perform
Company TORNIER, INC.
Model IFX615
Catalog number IFX615
Device description Fracture XRO Humeral Head Trial
Published 2022-12-21
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 HWT TEMPLATE
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HWT Template Orthopedic 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00846832086504 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00846832086504 00846832086504 846832086504 0846832086504
GMDN Terms# Term, Definition table Term Definition Humeral head prosthesis trial, reusable A copy of a final humeral head prosthesis designed to be used before primary or revision implant surgery to validate the proper size of the permanent prosthesis required by the patient, to ensure its proper orientation and positioning, and to verify that the implant site has been cut to the proper dimensions. It has a cup-like ball shape and is available in types such as concentric head fixation, eccentric head fixation, cuff tear arthropathy (CTA), or types for revision surgery. It is typically made of metal and/or polymer. This is a reusable device intended to be sterilized prior to use.
Device Sizes# Type, Value, Unit table Type Value Unit Height 18 Millimeter Outer Diameter 48 Millimeter
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 968990812 Device count 1 Premarket exempt true Lot or batch true Manufacturing date on label true Expiration 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 00840338612656 Made-To-Order 9027479 9027479 2026-10-21 00846832085675 TORNIER PERFORM™ REVERSED DWJ1017304 DWJ1017304 2022-01-05 00846832085682 TORNIER PERFORM™ REVERSED DWJ1017305 DWJ1017305 2022-01-05 00846832085699 TORNIER PERFORM™ REVERSED DWJ1017306 DWJ1017306 2022-01-05 00846832085705 TORNIER PERFORM™ REVERSED DWJ1017307 DWJ1017307 2022-01-05 00846832085743 TORNIER PERFORM™ REVERSED DWJ1017204 DWJ1017204 2022-01-05 00846832085750 TORNIER PERFORM™ REVERSED DWJ1017205 DWJ1017205 2022-01-05 00846832085767 TORNIER PERFORM™ REVERSED DWJ1017206 DWJ1017206 2022-01-05 00846832085774 TORNIER PERFORM™ REVERSED DWJ1017207 DWJ1017207 2022-01-05 00846832085781 TORNIER PERFORM™ REVERSED DWJ1017701 DWJ1017701 2022-01-05 00846832085798 TORNIER PERFORM™ REVERSED DWJ1017702 DWJ1017702 2022-01-05 00846832085804 TORNIER PERFORM™ REVERSED DWJ1017703 DWJ1017703 2022-01-05 00846832085811 TORNIER PERFORM™ REVERSED DWJ1017601 DWJ1017601 2022-01-05 00846832085828 TORNIER PERFORM™ REVERSED DWJ1017602 DWJ1017602 2022-01-05 00846832085835 TORNIER PERFORM™ REVERSED DWJ1017603 DWJ1017603 2022-01-05 00846832092086 Tornier Perform® Reversed Augmented Glenoid DWJ513 DWJ513 2022-05-10 00846832092093 Tornier Perform® Reversed Augmented Glenoid DWJ503 DWJ503 2022-05-10 00846832092109 Tornier Perform® Reversed Augmented Glenoid DWJ505 DWJ505 2022-05-10 00846832092123 Tornier Perform® Reversed Augmented Glenoid DWJ502 DWJ502 2022-05-10 00846832092130 Tornier Perform® Reversed Augmented Glenoid DWJ514 DWJ514 2022-05-10
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