ADDplus™ anterior distraction device plus CS 2253-12-40

GUDID 04052536009381

ADDplus, ø 12 mm, height 40-65 mm, angle 18°

Ulrich GmbH & Co. KG

Vertebral body prosthesis, non-sterile

• Primary Device ID: 04052536009381
• NIH Device Record Key: b7ec706a-ca66-4e5c-82f4-23bfef69f7e5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ADDplus™ anterior distraction device plus
• Version Model Number: CS 2253-12-40
• Catalog Number: CS 2253-12-40
• 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
• Phone: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com
• Phone: +4907319654152
• Email: safety@ulrichmedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04052536009381 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090841

FDA Product Code

• MQP: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Sterilization

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

[04052536009381]

Moist Heat or Steam Sterilization

[04052536009381]

Moist Heat or Steam Sterilization

[04052536009381]

Moist Heat or Steam Sterilization

[04052536009381]

Moist Heat or Steam Sterilization

[04052536009381]

Moist Heat or Steam Sterilization

[04052536009381]

Moist Heat or Steam Sterilization

[04052536009381]

Moist Heat or Steam Sterilization

[04052536009381]

Moist Heat or Steam Sterilization

[04052536009381]

Moist Heat or Steam Sterilization

[04052536009381]

Moist Heat or Steam Sterilization

[04052536009381]

Moist Heat or Steam Sterilization

[04052536009381]

Moist Heat or Steam Sterilization

[04052536009381]

Moist Heat or Steam Sterilization

[04052536009381]

Moist Heat or Steam Sterilization

[04052536009381]

Moist Heat or Steam Sterilization

[04052536009381]

Moist Heat or Steam Sterilization

[04052536009381]

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 [ADDplus™ anterior distraction device plus]

• 04052536009381: ADDplus, ø 12 mm, height 40-65 mm, angle 18°
• 04052536009374: ADDplus, ø 12 mm, height 25-41 mm, angle 12°
• 04052536009367: ADDplus, ø 12 mm, height 17-26 mm, angle 6°
• 04052536009350: ADDplus, ø 12 mm, height 13-18 mm, angle 0°