EXCELSIUSGPS

GUDID 00193982618131

Lateral Trial, 22 x 40-60mm, 9mm, 10°, FH, GPS

GLOBUS MEDICAL, INC.

Robotic surgical navigation system

• Primary Device ID: 00193982618131
• NIH Device Record Key: f7548d86-0470-4dc1-af2c-fac7562e273f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EXCELSIUSGPS
• Version Model Number: 6255.1409
• 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	00193982618131 [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

[00193982618131]

Moist Heat or Steam Sterilization

[00193982618131]

Moist Heat or Steam Sterilization

[00193982618131]

Moist Heat or Steam Sterilization

[00193982618131]

Moist Heat or Steam Sterilization

[00193982618131]

Moist Heat or Steam Sterilization

[00193982618131]

Moist Heat or Steam Sterilization

[00193982618131]

Moist Heat or Steam Sterilization

[00193982618131]

Moist Heat or Steam Sterilization

[00193982618131]

Moist Heat or Steam Sterilization

[00193982618131]

Moist Heat or Steam Sterilization

[00193982618131]

Moist Heat or Steam Sterilization

[00193982618131]

Moist Heat or Steam Sterilization

[00193982618131]

Moist Heat or Steam Sterilization

[00193982618131]

Moist Heat or Steam Sterilization

[00193982618131]

Moist Heat or Steam Sterilization

[00193982618131]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-12-09
• Device Publish Date: 2024-12-01

On-Brand Devices [EXCELSIUSGPS]

• 00193982619701: 3.0Nm Torque Driver, FH, GPS
• 00193982619626: Lateral Trial, 20 x 35-65mm, 9mm, 6°, FH, GPS
• 00193982619619: Lateral Trial, 20 x 35-65mm, 7mm, 6°, FH, GPS
• 00193982619602: Lateral Trial, 20 x 35-65mm, 5mm, 6°, FH, GPS
• 00193982619459: Lateral Trial, 20 x 35-65mm, 11mm, 15°, FH, GPS
• 00193982619381: Lateral Trial, 22 x 40-60, 17mm, Parallel, CC Angled, FH, GPS
• 00193982619374: Lateral Trial, 22 x 40-60, 15mm, Parallel, CC Angled, FH, GPS
• 00193982619367: Lateral Trial, 22 x 40-60, 13mm, Parallel, CC Angled, FH, GPS
• 00193982619350: Lateral Trial, 22 x 40-60, 11mm, Parallel, CC Angled, FH, GPS
• 00193982619343: Lateral Trial, 22 x 40-60, 9mm, Parallel, CC Angled, FH, GPS
• 00193982619336: Lateral Trial, 22 x 40-60, 7mm, Parallel, CC Angled, FH, GPS
• 00193982619329: Lateral Trial, 22 x 40-60, 5mm, Parallel, CC Angled, FH, GPS
• 00193982619312: Lateral Trial, 22 x 40-60, 17mm, 6°, ATP Angled, FH, GPS
• 00193982619305: Lateral Trial, 22 x 40-60, 15mm, 6°, ATP Angled, FH, GPS
• 00193982619299: Lateral Trial, 22 x 40-60, 13mm, 6°, ATP Angled, FH, GPS
• 00193982619282: Lateral Trial, 22 x 40-60, 11mm, 6°, ATP Angled, FH, GPS
• 00193982619275: Lateral Trial, 22 x 40-60, 9mm, 6°, ATP Angled, FH, GPS
• 00193982619268: Lateral Trial, 22 x 40-60, 7mm, 6°, ATP Angled, FH, GPS
• 00193982619251: Lateral Trial, 22 x 40-60, 5mm, 6°, ATP Angled, FH, GPS
• 00193982619244: Lateral Trial, 18 x 40-60, 17mm, 6°, ATP Angled, FH, GPS
• 00193982619237: Lateral Trial, 18 x 40-60, 15mm, 6°, ATP Angled, FH, GPS
• 00193982619220: Lateral Trial, 18 x 40-60, 13mm, 6°, ATP Angled, FH, GPS
• 00193982619213: Lateral Trial, 18 x 40-60, 11mm, 6°, ATP Angled, FH, GPS
• 00193982619206: Lateral Trial, 18 x 40-60, 9mm, 6°, ATP Angled, FH, GPS
• 00193982619190: Lateral Trial, 18 x 40-60, 7mm, 6°, ATP Angled, FH, GPS
• 00193982619183: Lateral Trial, 18 x 40-60, 5mm, 6°, ATP Angled, FH, GPS
• 00193982619176: Lateral Trial, 20 x 35-60, 9mm, 6°, ATP Angled, FH, GPS
• 00193982619169: Lateral Trial, 20 x 35-60, 7mm, 6°, ATP Angled, FH, GPS
• 00193982619152: Lateral Trial, 20 x 35-60, 5mm, 6°, ATP Angled, FH, GPS
• 00193982619084: 25° Angled Lateral Inserter, Expandable, FH, GPS
• 00193982619077: Lateral Cup Curette, Angled, Up, 6.5 x 9.5mm, 15°, FH, GPS
• 00193982619060: Lateral Cup Curette, Angled, Down, 6.5 x 9.5mm, 15°, FH, GPS
• 00193982619053: Lateral Cup Curette, Angled, Up, 6.5 x 9.5mm, FH, GPS
• 00193982619046: Lateral Cup Curette, Angled, Down, 6.5 x 9.5mm, FH, GPS
• 00193982619039: Lateral Rake, ATP Angled, FH, GPS
• 00193982619022: Lateral Distractor, 8mm, ATP Angled, FH, GPS
• 00193982619015: Lateral Distractor, 6mm, ATP Angled, FH, GPS
• 00193982619008: Lateral Distractor, 4mm, ATP Angled, FH, GPS
• 00193982618995: Lateral Cobb Elevator, 10mm, 7°, ATP Angled, Up, FH, GPS
• 00193982618988: Lateral Cobb Elevator, 10mm, 7°, ATP Angled, Down, FH, GPS
• 00193982618971: Lateral Cobb Elevator, 22mm, ATP Angled, Up, FH, GPS
• 00193982618964: Lateral Cobb Elevator 22mm, ATP Angled, Down, FH, GPS
• 00193982618957: Lateral Cobb Elevator, 18mm, ATP Angled, Up, FH, GPS
• 00193982618940: Lateral Cobb Elevator, 18mm, ATP Angled, Down, FH, GPS
• 00193982618933: Lateral Cobb Elevator, 20mm, 7°, ATP Angled, Up, FH, GPS
• 00193982618926: Lateral Cobb Elevator, 20mm, 7°, ATP Angled, Down, FH, GPS
• 00193982618919: Lateral Cobb Elevator, 20mm, ATP Angled, Up, FH, GPS
• 00193982618902: Lateral Cobb Elevator, 20mm, ATP Angled, Down, FH, GPS
• 00193982618896: Lateral Ring Curette, 10mm, 7°, ATP Angled, Up, FH, GPS
• 00193982618889: Lateral Ring Curette, 10mm, 7°, ATP Angled, Down, FH, GPS