EXCELSIUS GPS

GUDID 00193982143053

Dilator Array, GPS

GLOBUS MEDICAL, INC.

Robotic surgical navigation system

• Primary Device ID: 00193982143053
• NIH Device Record Key: 6dd10f9c-8d26-4aee-8c5f-5c98726a991a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EXCELSIUS GPS
• Version Model Number: 6143.1115
• Company DUNS: 139105691
• Company Name: GLOBUS MEDICAL, INC.
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00193982143053 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191100

FDA Product Code

• OLO: Orthopedic stereotaxic instrument

Sterilization

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

[00193982143053]

Moist Heat or Steam Sterilization

[00193982143053]

Moist Heat or Steam Sterilization

[00193982143053]

Moist Heat or Steam Sterilization

[00193982143053]

Moist Heat or Steam Sterilization

[00193982143053]

Moist Heat or Steam Sterilization

[00193982143053]

Moist Heat or Steam Sterilization

[00193982143053]

Moist Heat or Steam Sterilization

[00193982143053]

Moist Heat or Steam Sterilization

[00193982143053]

Moist Heat or Steam Sterilization

[00193982143053]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-07-21
• Device Publish Date: 2020-07-13

On-Brand Devices [EXCELSIUS GPS]

• 00889095998511: End Effector Sleeve, 15mm
• 00889095998504: End Effector Sleeve, 17mm
• 00889095998498: Cannula A, 9mm x 250mm
• 00889095998481: Ball tip Probe
• 00889095995176: 6.35 Rod Attachment, Long
• 00889095995169: 6.35 Rod Attachment, Short
• 00889095375596: SI-LOK Drill, 7.5mm, GPS
• 00193982143459: RISE Torque Limiting Driver, 2.0Nm
• 00193982143299: Inserter Body, RISE/CALIBER Inserter, GPS
• 00193982143282: CALIBER Torque Limiting Driver, 2.0Nm
• 00193982143268: CALIBER Sleeve, RISE/CALIBER Inserter, GPS
• 00193982143251: CALIBER Fork, 12mm, RISE/CALIBER Inserter, GPS
• 00193982143244: CALIBER Fork, 10mm, RISE/CALIBER Inserter, GPS
• 00193982143237: Verification Adapter, CALIBER Inserter Fork, 12mm
• 00193982143220: Verification Adapter, CALIBER Inserter Fork, 10mm
• 00193982143213: RISE Sleeve, RISE/CALIBER Inserter, GPS
• 00193982143206: RISE Fork, 12mm, RISE/CALIBER Inserter, GPS
• 00193982143190: RISE Fork, 10mm, RISE/CALIBER Inserter, GPS
• 00193982143183: RISE Fork, 8mm, RISE/CALIBER Inserter, GPS
• 00193982143176: Verification Adapter, RISE Inserter Fork, 12mm
• 00193982143169: Verification Adapter, RISE Inserter Fork, 10mm
• 00193982143152: Verification Adapter, RISE Inserter Fork, 8mm
• 00193982143107: Torque-Limiting Driver, 3.0Nm, RISE-L/ELSA Inserter
• 00193982143091: RISE-L/ELSA Inserter, GPS
• 00193982143084: Verification Adapter, RISE-L/ELSA Inserter
• 00193982143077: Wrench, RISE-L/ELSA Inserter
• 00193982143053: Dilator Array, GPS
• 00193982143046: Array T-Handle, 90°, Grey 6, GPS
• 00193982143039: Array T-Handle, 90°, Purple 5, GPS
• 00193982143022: Array Handle, 180°, Blue 4, GPS
• 00193982143015: Array Handle, 180°, Green 3, GPS
• 00193982143008: Array Handle, 180°, Gold 2, GPS
• 00193982142995: Array Handle, 180°, Red 1, GPS
• 00193982142926: Posterior Trial, 10 x 22mm, 15mm, GPS
• 00193982142919: Posterior Trial, 10 x 22mm, 14mm, GPS
• 00193982142902: Posterior Trial, 10 x 22mm, 13mm, GPS
• 00193982142896: Posterior Trial, 10 x 22mm, 12mm, GPS
• 00193982142889: Posterior Trial, 10 x 22mm, 11mm, GPS
• 00193982142872: Posterior Trial, 10 x 22mm, 10mm, GPS
• 00193982142865: Posterior Trial, 10 x 22mm, 9mm, GPS
• 00193982142858: Posterior Trial, 10 x 22mm, 8mm, GPS
• 00193982142841: Posterior Trial, 10 x 22mm, 7mm, GPS
• 00193982142834: Posterior Trial, 10 x 22mm, 6mm, GPS
• 00193982142827: Posterior Trial, 10 x 22mm, 5mm, GPS
• 00193982142797: Posterior Trial, 8 x 22mm, 15mm, GPS
• 00193982142780: Posterior Trial, 8 x 22mm, 14mm, GPS
• 00193982142773: Posterior Trial, 8 x 22mm, 13mm, GPS
• 00193982142766: Posterior Trial, 8 x 22mm, 12mm, GPS
• 00193982142759: Posterior Trial, 8 x 22mm, 11mm, GPS
• 00193982142742: Posterior Trial, 8 x 22mm, 10mm, GPS