ACIF

GUDID 07640173166603

oscar cage

coLigne AG

Polymeric spinal interbody fusion cage

• Primary Device ID: 07640173166603
• NIH Device Record Key: bb9c6684-3a35-4ee5-a395-4f915eab48ad
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACIF
• Version Model Number: 4378
• Company DUNS: 482467792
• Company Name: coLigne AG
• 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: +41433438000
• Email: info@coligne.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640173166603 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173148

FDA Product Code

• ODP: Intervertebral Fusion Device With Bone Graft, Cervical

Sterilization

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

[07640173166603]

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: 2018-01-23

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