MD-Vue Lateral Access System 54-BK-1000

GUDID 00840019936460

Instrument Kit

PRECISION SPINE, INC.

Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable

• Primary Device ID: 00840019936460
• NIH Device Record Key: 408e49eb-e467-46ac-8eab-2cfc39cda033
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MD-Vue Lateral Access System
• Version Model Number: 54-BK-1000
• Catalog Number: 54-BK-1000
• Company DUNS: 079398589
• Company Name: PRECISION SPINE, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840019936460 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092193

FDA Product Code

• KWQ: Appliance, Fixation, Spinal Intervertebral Body

Sterilization

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

[00840019936460]

Moist Heat or Steam Sterilization

[00840019936460]

Moist Heat or Steam Sterilization

[00840019936460]

Moist Heat or Steam Sterilization

[00840019936460]

Moist Heat or Steam Sterilization

[00840019936460]

Moist Heat or Steam Sterilization

[00840019936460]

Moist Heat or Steam Sterilization

[00840019936460]

Moist Heat or Steam Sterilization

[00840019936460]

Moist Heat or Steam Sterilization

[00840019936460]

Moist Heat or Steam Sterilization

[00840019936460]

Moist Heat or Steam Sterilization

[00840019936460]

Moist Heat or Steam Sterilization

[00840019936460]

Moist Heat or Steam Sterilization

[00840019936460]

Moist Heat or Steam Sterilization

[00840019936460]

Moist Heat or Steam Sterilization

[00840019936460]

Moist Heat or Steam Sterilization

[00840019936460]

Moist Heat or Steam Sterilization

[00840019936460]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-03-16
• Device Publish Date: 2023-03-08

On-Brand Devices [MD-Vue Lateral Access System]

• 00840019936484: Light Cable Kit
• 00840019936477: Table Arm Kit
• 00840019936460: Instrument Kit