flamenco™, tangoRS™, cosmicMIA™ CS 8018-02

GUDID 04052536021796

flamenco rod-rod-connector, axial, ø 5.5 to 6.0 mm

Ulrich GmbH & Co. KG

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 04052536021796
• NIH Device Record Key: d6fbfb0d-cdd5-426c-84e1-4acf1dde749d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: flamenco™, tangoRS™, cosmicMIA™
• Version Model Number: CS 8018-02
• Catalog Number: CS 8018-02
• Company DUNS: 315494757
• Company Name: Ulrich GmbH & Co. KG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +4907319654152
• Email: safety@ulrichmedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04052536021796 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102853

FDA Product Code

• KWP: APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Sterilization

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

[04052536021796]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-07-30

On-Brand Devices [flamenco™, tangoRS™, cosmicMIA™]

• 04052536021796: flamenco rod-rod-connector, axial, ø 5.5 to 6.0 mm
• 04052536021772: flamenco rod-rod-connector, parallel, ø 5.5 to 6.0 mm