MD Vue Lateral Access 54-SC-1000

GUDID 00840019919685

Instrument Case (Empty)

PRECISION SPINE, INC.

Orthopaedic surgical procedure kit, non-medicated, reusable

• Primary Device ID: 00840019919685
• NIH Device Record Key: 1a9c92b7-5c24-453c-a335-e75082dd2474
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MD Vue Lateral Access
• Version Model Number: 54-SC-1000
• Catalog Number: 54-SC-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: false
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840019919685 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092193

Sterilization

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

[00840019919685]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-04-05
• Device Publish Date: 2019-03-28

On-Brand Devices [ MD Vue Lateral Access ]

• 00840019919708: Light Cable Case (Empty)
• 00840019919678: 30mm Serial Dilator
• 00840019919661: 25mm Serial Dilator
• 00840019919647: Anterior Retractor Bridge, Small
• 00840019919623: Fluoromodulator
• 00840019919616: Cruciform Incision Locator
• 00840019919609: Disposable Bipolar Forceps
• 00840019919593: Bifurcated Illuminator
• 00840019919586: Light Cable
• 00840019919579: Bipolar Forceps - 8" 1mm Straight Tips
• 00840019919562: Penfield Distractor - Bayonetted
• 00840019919555: Penfield Distractor - Long, Straight
• 00840019919548: Penfield Distractor - Short, Straight
• 00840019919531: Suction Instruments - 10 Fr Long
• 00840019919524: Suction Instruments - 8 Fr Long
• 00840019919517: Fixation Pin Driver
• 00840019919494: 180mm Wide Anterior Retractor
• 00840019919487: 180mm Narrow Anterior Retractor
• 00840019919470: 140mm Wide Anterior Retractor
• 00840019919463: 140mm Narrow Anterior Retractor
• 00840019919456: Retractor Anterior Arm
• 00840019919449: Posterior Lobe Handle
• 00840019919432: Retractor Handle - Cephalad/Caudal
• 00840019919425: Retractor Body
• 00840019919418: Shim Remover
• 00840019919401: Shim Inserter / Impactor
• 00840019919395: 25mm Widening Shim Left
• 00840019919388: 25mm Widening Shim Right
• 00840019919371: 10mm Lengthening Shim
• 00840019919340: 20mm Posterior Shim
• 00840019919333: 180mm Posterior Blade
• 00840019919326: 170mm Posterior Blade
• 00840019919319: 160mm Posterior Blade
• 00840019919302: 150mm Posterior Blade
• 00840019919296: 140mm Posterior Blade
• 00840019919272: 120mm Posterior Blade
• 00840019919258: 100mm Posterior Blade
• 00840019919241: 90mm Posterior Blade
• 00840019919234: 80mm Posterior Blade
• 00840019919210: 180mm Left Blade
• 00840019919203: 170mm Left Blade
• 00840019919180: 54-BL-0150
• 00840019919173: 140mm Left Blade
• 00840019919166: 54-BL-0130
• 00840019919159: 120mm Left Blade
• 00840019919135: 100mm Left Blade
• 00840019919111: 80mm Left Blade
• 00840019919104: 70mm Left Blade
• 00840019919067: 150mm Right Blade
• 00840019919050: 140mm Right Blade