RONDO' VT-66135

GUDID 08051739534658

CITIEFFE SRL

Orthopaedic bone screw, non-bioabsorbable, sterile

• Primary Device ID: 08051739534658
• NIH Device Record Key: 008ffd61-0257-424b-abb8-a0255d81e2d8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RONDO'
• Version Model Number: Screw ø6.5mm L135-32mm
• Catalog Number: VT-66135
• Company DUNS: 431406875
• Company Name: CITIEFFE SRL
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +39051721850
• Email: info@citieffe.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Dry and clean environment and avoid damaging the packing. Room temperature.

Device Identifiers

Device Issuing Agency	Device ID
GS1	08051739534658 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113388

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-02-19
• Device Publish Date: 2019-02-18