SIros Navigated Instruments G11017

GUDID M719G110170

SI Navigated Instruments Case

Genesys Orthopedics Systems LLC

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• Primary Device ID: M719G110170
• NIH Device Record Key: 1285c77c-c7f1-4ab3-adbc-a7fd9a293914
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SIros Navigated Instruments
• Version Model Number: 1
• Catalog Number: G11017
• Company DUNS: 017921066
• Company Name: Genesys Orthopedics Systems LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 5123817070
• Email: info@genesysspine.com
• Phone: 5123817070
• Email: info@genesysspine.com
• Phone: 5123817070
• Email: info@genesysspine.com
• Phone: 5123817070
• Email: info@genesysspine.com
• Phone: 5123817070
• Email: info@genesysspine.com
• Phone: 5123817070
• Email: info@genesysspine.com
• Phone: 5123817070
• Email: info@genesysspine.com
• Phone: 5123817070
• Email: info@genesysspine.com
• Phone: 5123817070
• Email: info@genesysspine.com
• Phone: 5123817070
• Email: info@genesysspine.com
• Phone: 5123817070
• Email: info@genesysspine.com
• Phone: 5123817070
• Email: info@genesysspine.com
• Phone: 5123817070
• Email: info@genesysspine.com
• Phone: 5123817070
• Email: info@genesysspine.com
• Phone: 5123817070
• Email: info@genesysspine.com
• Phone: 5123817070
• Email: info@genesysspine.com
• Phone: 5123817070
• Email: info@genesysspine.com
• Phone: 5123817070
• Email: info@genesysspine.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M719G110170 [Primary]

FDA Product Code

• OUR: Sacroiliac Joint Fixation

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[M719G110170]

Moist Heat or Steam Sterilization

[M719G110170]

Moist Heat or Steam Sterilization

[M719G110170]

Moist Heat or Steam Sterilization

[M719G110170]

Moist Heat or Steam Sterilization

[M719G110170]

Moist Heat or Steam Sterilization

[M719G110170]

Moist Heat or Steam Sterilization

[M719G110170]

Moist Heat or Steam Sterilization

[M719G110170]

Moist Heat or Steam Sterilization

[M719G110170]

Moist Heat or Steam Sterilization

[M719G110170]

Moist Heat or Steam Sterilization

[M719G110170]

Moist Heat or Steam Sterilization

[M719G110170]

Moist Heat or Steam Sterilization

[M719G110170]

Moist Heat or Steam Sterilization

[M719G110170]

Moist Heat or Steam Sterilization

[M719G110170]

Moist Heat or Steam Sterilization

[M719G110170]

Moist Heat or Steam Sterilization

[M719G110170]

Moist Heat or Steam Sterilization

[M719G110170]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-04-09
• Device Publish Date: 2024-04-01

On-Brand Devices [SIros Navigated Instruments ]

• M719GSI2461350: 13.5mm SI Navigated Large Bore Drill
• M719GSI2461150: 11.5mm SI Navigated Large Bore Drill
• M719GSI2460950: 9.5mm SI Navigated Large Bore Drill
• M719GSI2460850: 8.5mm SI Navigated Large Bore Drill
• M719GSI2460700: 7.0mm SI Navigated Large Bore Drill
• M719GSI2451350: 13.5mm SI Navigated Drill
• M719GSI2451150: 11.5mm SI Navigated Drill
• M719GSI2450950: 9.5mm SI Navigated Drill
• M719GSI2450850: 8.5mm SI Navigated Drill
• M719GSI2450700: 7.0mm SI Navigated Drill
• M719GSI244030: SI Navigated Drill Sleeve, XLB to LB
• M719GSI244020: SI Navigated Drill Sleeve, XLB to Standard
• M719GSI244010: SI Navigated Drill Sleeve, LB to Standard
• M719GSI243XLS0: SI Navigated Spiked X-Large Drill Guide - Straight Tip Assembly
• M719GSI243XLA0: SI Navigated Spiked X-Large Drill Guide - Angeled Tip Assembly
• M719GSI243STS0: SI Navigated Spiked Standard Drill Guide - Straight Tip Assembly
• M719GSI243STA0: SI Navigated Spiked Standard Drill Guide - Angeled Tip Assembly
• M719GSI243LGS0: SI Navigated Spiked Large Drill Guide - Straight Tip Assembly
• M719GSI243LGA0: SI Navigated Spiked Large Drill Guide - Angeled Tip Assembly
• M719GSI242XLS0: SI Navigated X-Large Drill Guide - Straight Tip Assembly
• M719GSI242XLA0: SI Navigated X-Large Drill Guide - Angeled Tip Assembly
• M719GSI242STS0: SI Navigated Standard Drill Guides - Straight Tip Assembly
• M719GSI242STA0: SI Navigated Standard Drill Guides - Angeled Tip Assembly
• M719GSI242LGS0: SI Navigated Large Bore Drill Guides - Straight Tip Assembly
• M719GSI242LGA0: SI Navigated Large Bore Drill Guides - Angeled Tip Assembly
• M719GSI2410: SI Navigated Friction Screw Driver
• M719GSI2400: SI Navigated Screw Driver
• M719G110190: SI Navigated Instruments Lid
• M719G110180: SI Navigated Instruments Tray
• M719G110170: SI Navigated Instruments Case