RISE-L

GUDID 00889095308105

RISE-L Spacer 18 x 35mm, 7-14mm, 3-15°

GLOBUS MEDICAL, INC.

Metallic spinal interbody fusion cage

• Primary Device ID: 00889095308105
• NIH Device Record Key: a2430bb8-de65-476e-8551-804357836fba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RISE-L
• Version Model Number: 193.501
• 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: true
• 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

Customer Support Contacts

• Phone: +1(610)930-1800
• Email: info@globusmedical.com

Device Dimensions

• Height: 7 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889095308105 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113447

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

Sterilization

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

[00889095308105]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-24
• Device Publish Date: 2015-12-17

On-Brand Devices [RISE-L]

• 00889095308235: RISE-L Spacer 22 x 65mm, 7-14mm, 3-15°
• 00889095308228: RISE-L Spacer 22 x 60mm, 7-14mm, 3-15°
• 00889095308211: RISE-L Spacer 22 x 55mm, 7-14mm, 3-15°
• 00889095308204: RISE-L Spacer 22 x 50mm, 7-14mm, 3-15°
• 00889095308198: RISE-L Spacer 22 x 45mm, 7-14mm, 3-15°
• 00889095308181: RISE-L Spacer 22 x 40mm, 7-14mm, 3-15°
• 00889095308174: RISE-L Spacer 22 x 35mm, 7-14mm, 3-15°
• 00889095308167: RISE-L Spacer 18 x 65mm, 7-14mm, 3-15°
• 00889095308150: RISE-L Spacer 18 x 60mm, 7-14mm, 3-15°
• 00889095308143: RISE-L Spacer 18 x 55mm, 7-14mm, 3-15°
• 00889095308136: RISE-L Spacer 18 x 50mm, 7-14mm, 3-15°
• 00889095308129: RISE-L Spacer 18 x 45mm, 7-14mm, 3-15°
• 00889095308112: RISE-L Spacer 18 x 40mm, 7-14mm, 3-15°
• 00889095308105: RISE-L Spacer 18 x 35mm, 7-14mm, 3-15°