Home GUDID M697X07900081 Silex Sacroiliac Joint Fusion System
Primary DI M697X07900081
Brand Silex Sacroiliac Joint Fusion System
Company Xtant Medical Holdings, Inc.
Model X079-0008
Device description STERILIZATION CASE ADDITIONAL INSTRUMENTS SILEX
Published 2026-07-08
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name FSM Tray, Surgical, Instrument
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FSM Tray, Surgical, Instrument General, Plastic Surgery 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status M697X07900081 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Instrument tray, reusable A container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 081224143 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00190776422011 Millennium Avalign Technologies, Inc. FSM 2026-07-24 00840536823717 VerteGlide Spinal Growth Guidance System ORTHOPEDIATRICS CORP. FSM 2026-07-24 00840536823724 VerteGlide Spinal Growth Guidance System ORTHOPEDIATRICS CORP. FSM 2026-07-24 07640221370846 SCALA SpineArt SA FSM 2026-07-24 07640221370853 SCALA SpineArt SA FSM 2026-07-24 07640221370860 SCALA SpineArt SA FSM 2026-07-24 00190776421991 Millennium Avalign Technologies, Inc. FSM 2026-07-23 00190776422004 Millennium Avalign Technologies, Inc. FSM 2026-07-23 18059015378368 Flexible Reamers System ORTHOFIX SRL FSM 2026-07-23 18059015378375 Flexible Reamers System ORTHOFIX SRL FSM 2026-07-23 18059015378382 Flexible Reamers System ORTHOFIX SRL FSM 2026-07-23 00841731153258 ARTEMIS FUZE VILEX LLC FSM 2026-07-22 00841731153265 ARTEMIS TAKEDOWN VILEX LLC FSM 2026-07-22 B803PW12A0 ORTHOMED ORTHO-MED, INC. FSM 2026-07-22 B803PW14G0 ORTHOMED ORTHO-MED, INC. FSM 2026-07-22 B803PW18A0 ORTHOMED ORTHO-MED, INC. FSM 2026-07-22 B803PW20 ORTHOMED ORTHO-MED, INC. FSM 2026-07-22 B803PW22A0 ORTHOMED ORTHO-MED, INC. FSM 2026-07-22 B803PW26A0 ORTHOMED ORTHO-MED, INC. FSM 2026-07-22 B803PW30A0 ORTHOMED ORTHO-MED, INC. FSM 2026-07-22 B803PW32A0 ORTHOMED ORTHO-MED, INC. FSM 2026-07-22 B803PW40A0 ORTHOMED ORTHO-MED, INC. FSM 2026-07-22 B803PW6G0 ORTHOMED ORTHO-MED, INC. FSM 2026-07-22 00840606195737 Viaduct SPINAL ELEMENTS, INC. FSM 2026-07-20 00843059127478 Lattus TEDAN SURGICAL INNOVATIONS, L.L.C. FSM 2026-07-20 07613327602241 NA Stryker Leibinger GmbH & Co. KG FSM 2026-07-17 07613327602296 NA Stryker Leibinger GmbH & Co. KG FSM 2026-07-17 07613327602302 NA Stryker Leibinger GmbH & Co. KG FSM 2026-07-17 07613327602326 NA Stryker Leibinger GmbH & Co. KG FSM 2026-07-17 07613327602418 NA Stryker Leibinger GmbH & Co. KG FSM 2026-07-17
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