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 B382SD923300150 Surgical Direct Surgical Direct, Inc. FSM 2026-08-07 B382SD923301040 Surgical Direct Surgical Direct, Inc. FSM 2026-08-07 00840606192002 Overwatch PCF SPINAL ELEMENTS, INC. FSM 2026-07-31 00840606192019 Overwatch PCF SPINAL ELEMENTS, INC. FSM 2026-07-31 00840606192026 Overwatch PCF SPINAL ELEMENTS, INC. FSM 2026-07-31 00840606192033 Overwatch PCF SPINAL ELEMENTS, INC. FSM 2026-07-31 00840606192040 Overwatch PCF SPINAL ELEMENTS, INC. FSM 2026-07-31 00840606194884 Overwatch PCF SPINAL ELEMENTS, INC. FSM 2026-07-31 00840606194891 Overwatch PCF SPINAL ELEMENTS, INC. FSM 2026-07-31 00840606194907 Overwatch PCF SPINAL ELEMENTS, INC. FSM 2026-07-31 00840606194914 Overwatch PCF SPINAL ELEMENTS, INC. FSM 2026-07-31 00840606194921 Overwatch PCF SPINAL ELEMENTS, INC. FSM 2026-07-31 00840606194938 Overwatch PCF SPINAL ELEMENTS, INC. FSM 2026-07-31 00840606194945 Overwatch PCF SPINAL ELEMENTS, INC. FSM 2026-07-31 00840606194952 Overwatch PCF SPINAL ELEMENTS, INC. FSM 2026-07-31 00840606194969 Overwatch PCF SPINAL ELEMENTS, INC. FSM 2026-07-31 00840606194976 Overwatch PCF SPINAL ELEMENTS, INC. FSM 2026-07-31 00840606194983 Overwatch PCF SPINAL ELEMENTS, INC. FSM 2026-07-31 00840606194990 Overwatch PCF SPINAL ELEMENTS, INC. FSM 2026-07-31 00840606195003 Overwatch PCF SPINAL ELEMENTS, INC. FSM 2026-07-31 00840606195010 Overwatch PCF SPINAL ELEMENTS, INC. FSM 2026-07-31 00840606195027 Overwatch PCF SPINAL ELEMENTS, INC. FSM 2026-07-31 00840606195034 Overwatch PCF SPINAL ELEMENTS, INC. FSM 2026-07-31 00840606195041 Overwatch PCF SPINAL ELEMENTS, INC. FSM 2026-07-31 00840606195058 Overwatch PCF SPINAL ELEMENTS, INC. FSM 2026-07-31 00840606195065 Overwatch PCF SPINAL ELEMENTS, INC. FSM 2026-07-31 00840606195539 Overwatch PCF SPINAL ELEMENTS, INC. FSM 2026-07-31 00840606195669 Overwatch PCF SPINAL ELEMENTS, INC. FSM 2026-07-31 00840606195676 Overwatch PCF SPINAL ELEMENTS, INC. FSM 2026-07-31 00840606195683 Overwatch PCF SPINAL ELEMENTS, INC. FSM 2026-07-31
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