SABLE

GUDID 00193982003524

Inserter Sleeve, ML

GLOBUS MEDICAL, INC.

Orthopaedic surgical procedure kit, non-medicated, reusable

• Primary Device ID: 00193982003524
• NIH Device Record Key: 1b8585f7-7197-4a52-a3c3-4c285c63e2ac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SABLE
• Version Model Number: 6172.0001
• 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	00193982003524 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192115

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

Sterilization

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

[00193982003524]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-03-05
• Device Publish Date: 2020-02-26

On-Brand Devices [SABLE]

• 00889095966183: SABLE Spacer, 10x30, 10-18mm, 22°
• 00889095966169: SABLE Spacer, 10x30, 10-17mm, 15°
• 00889095966145: SABLE Spacer, 10x30, 7-14mm, 15°
• 00889095966121: SABLE Spacer, 10x30, 9-16mm, 8°
• 00889095966107: SABLE Spacer, 10x30, 6-12mm, 8°
• 00889095966084: SABLE Spacer, 10x26, 9-17mm, 22°
• 00889095966060: SABLE Spacer, 10x26, 10-17mm, 15°
• 00889095966046: SABLE Spacer, 10x26, 7-14mm, 15°
• 00889095966022: SABLE Spacer, 10x26, 9-16mm, 8°
• 00889095966008: SABLE Spacer, 10x26, 6-12mm, 8°
• 00889095965940: SABLE Spacer, 10x22, 11-17mm, 22°
• 00889095965926: SABLE Spacer, 10x22, 9-15mm, 22°
• 00889095965902: SABLE Spacer, 10x22, 10-16mm, 15°
• 00889095965889: SABLE Spacer, 10x22, 7-13mm, 15°
• 00889095965865: SABLE Spacer, 10x22, 9-15mm, 8°
• 00889095965841: SABLE Spacer, 10x22, 6-12mm, 8°
• 00193982003616: Inserter Sleeve, CC
• 00193982003593: Driver, 30mm Length
• 00193982003586: Driver, 26mm Length
• 00193982003579: Driver, 22mm Length
• 00193982003562: Rigid Driver
• 00193982003531: Threaded Shaft
• 00193982003524: Inserter Sleeve, ML
• 00889095965780: SABLE Spacer, 8x22, 11-17mm, 22°
• 00889095965766: SABLE Spacer, 8x22, 9-15mm, 22°
• 00889095965742: SABLE Spacer, 8x22, 10-16mm, 15°
• 00889095965728: SABLE Spacer, 8x22, 7-13mm, 15°
• 00889095965704: SABLE Spacer, 8x22, 9-15mm, 8°
• 00889095965681: SABLE Spacer, 8x22, 6-12mm, 8°