4CIS VANE SPINE SYSTEM 4302-5536

GUDID 08800033350194

Spinal Rigid Rod, Ø5.5x35mm

SOLCO BIOMEDICAL CO.,LTD.

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 08800033350194
• NIH Device Record Key: 0065c48d-065b-4e0f-adbf-552b5a3950fa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 4CIS VANE SPINE SYSTEM
• Version Model Number: 4302-5536
• Catalog Number: 4302-5536
• Company DUNS: 687844241
• Company Name: SOLCO BIOMEDICAL CO.,LTD.
• 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: 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	08800033350194 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121615

FDA Product Code

• MNI: Orthosis, Spinal Pedicle Fixation

Sterilization

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

[08800033350194]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-04-03
• Device Publish Date: 2020-03-26

On-Brand Devices [4CIS VANE SPINE SYSTEM]

• 08806373545139: Persuader
• 08800033350217: Spinal Pre-bend Rod, Ø5.5x35mm
• 08800033350200: Spinal Pre-bend Rod, Ø5.5x30mm
• 08800033350194: Spinal Rigid Rod, Ø5.5x35mm
• 08800033350187: Spinal Rigid Rod, Ø5.5x30mm
• 08806373590382: Spinal Rigid Rod, Ø5.5x300mm