Home GUDID M697X07900530 Silex Sacroiliac Joint Fusion System
Primary DI M697X07900530
Brand Silex Sacroiliac Joint Fusion System
Company Xtant Medical Holdings, Inc.
Model X079-0053
Device description RIGHT ANGLE CURETTE
Published 2015-08-31
Public version status Update
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 HTF CURETTE
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HTF Curette General, Plastic Surgery 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status M697X07900530 Direct Marking HIBCC 0 M697X07900531 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Sacroiliac joint transarticular fixation/arthrodesis implantation kit A collection of non-sterile surgical instruments and devices intended to be used for the implantation of a sacroiliac joint transarticular fixation/arthrodesis implant during a minimally-invasive procedure. It typically consists of a tray, dedicated soft-tissue protectors, depth gauges, pin sleeves, drill sleeves, drill bits, broaches, a parallel pin guide, handles, slide hammer shafts, impactors, and a removal/adaptor tool; the implant(s) is not included. 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 00810168190464 NA PACIFIC INSTRUMENTS, INC. HTF 2026-07-06 B803PS0099100A0 ORTHOMED ORTHO-MED, INC. HTF 2026-06-26 B803PS00991080 ORTHOMED ORTHO-MED, INC. HTF 2026-06-26 B803PS0099108A0 ORTHOMED ORTHO-MED, INC. HTF 2026-06-26 B803PS00991090 ORTHOMED ORTHO-MED, INC. HTF 2026-06-26 B803PS0099109A0 ORTHOMED ORTHO-MED, INC. HTF 2026-06-26 B803PS00991100 ORTHOMED ORTHO-MED, INC. HTF 2026-06-26 B803PS0099110A0 ORTHOMED ORTHO-MED, INC. HTF 2026-06-26 B803PS0395900 ORTHOMED ORTHO-MED, INC. HTF 2026-06-26 B803PS03959000 ORTHOMED ORTHO-MED, INC. HTF 2026-06-26 B803PS039590000 ORTHOMED ORTHO-MED, INC. HTF 2026-06-26 B803PS0395910 ORTHOMED ORTHO-MED, INC. HTF 2026-06-26 B803PS0395920 ORTHOMED ORTHO-MED, INC. HTF 2026-06-26 B803PS0395930 ORTHOMED ORTHO-MED, INC. HTF 2026-06-26 B803PS0395950 ORTHOMED ORTHO-MED, INC. HTF 2026-06-26 B803PS0395960 ORTHOMED ORTHO-MED, INC. HTF 2026-06-26 B803PS0595940 ORTHOMED ORTHO-MED, INC. HTF 2026-06-26 B803PS00991010 ORTHOMED ORTHO-MED, INC. HTF 2026-06-25 B803PS0099101A0 ORTHOMED ORTHO-MED, INC. HTF 2026-06-25 B803PS00991020 ORTHOMED ORTHO-MED, INC. HTF 2026-06-25 B803PS0099102A0 ORTHOMED ORTHO-MED, INC. HTF 2026-06-25 B803PS00991030 ORTHOMED ORTHO-MED, INC. HTF 2026-06-25 B803PS0099103A0 ORTHOMED ORTHO-MED, INC. HTF 2026-06-25 B803PS00991040 ORTHOMED ORTHO-MED, INC. HTF 2026-06-25 B803PS0099104A0 ORTHOMED ORTHO-MED, INC. HTF 2026-06-25 B803PS00991050 ORTHOMED ORTHO-MED, INC. HTF 2026-06-25 B803PS0099105A0 ORTHOMED ORTHO-MED, INC. HTF 2026-06-25 B803PS00991060 ORTHOMED ORTHO-MED, INC. HTF 2026-06-25 B803PS0099106A0 ORTHOMED ORTHO-MED, INC. HTF 2026-06-25 B803PS00991070 ORTHOMED ORTHO-MED, INC. HTF 2026-06-25
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