ADD™ anterior distraction device CS 2250-16-246

GUDID 04052536009275

ADD/Small VBR, ø 16 mm, height 24-40 mm, angle 6°

Ulrich GmbH & Co. KG

Vertebral body prosthesis, non-sterile

• Primary Device ID: 04052536009275
• NIH Device Record Key: 40f1adef-85f9-49a0-a446-652042ed1b35
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ADD™ anterior distraction device
• Version Model Number: CS 2250-16-246
• Catalog Number: CS 2250-16-246
• 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
• Phone: +4973196540
• Email: safety@ulrichmedical.com
• Phone: +4973196540
• Email: safety@ulrichmedical.com
• Phone: +4973196540
• Email: safety@ulrichmedical.com
• Phone: +4973196540
• Email: safety@ulrichmedical.com
• Phone: +4973196540
• Email: safety@ulrichmedical.com
• Phone: +4973196540
• Email: safety@ulrichmedical.com
• Phone: +4973196540
• Email: safety@ulrichmedical.com
• Phone: +4973196540
• Email: safety@ulrichmedical.com
• Phone: +4973196540
• Email: safety@ulrichmedical.com
• Phone: +4973196540
• Email: safety@ulrichmedical.com
• Phone: +4973196540
• Email: safety@ulrichmedical.com
• Phone: +4973196540
• Email: safety@ulrichmedical.com
• Phone: +4973196540
• Email: safety@ulrichmedical.com
• Phone: +4973196540
• Email: safety@ulrichmedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04052536009275 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K012254

FDA Product Code

• MQP: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Sterilization

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

[04052536009275]

Moist Heat or Steam Sterilization

[04052536009275]

Moist Heat or Steam Sterilization

[04052536009275]

Moist Heat or Steam Sterilization

[04052536009275]

Moist Heat or Steam Sterilization

[04052536009275]

Moist Heat or Steam Sterilization

[04052536009275]

Moist Heat or Steam Sterilization

[04052536009275]

Moist Heat or Steam Sterilization

[04052536009275]

Moist Heat or Steam Sterilization

[04052536009275]

Moist Heat or Steam Sterilization

[04052536009275]

Moist Heat or Steam Sterilization

[04052536009275]

Moist Heat or Steam Sterilization

[04052536009275]

Moist Heat or Steam Sterilization

[04052536009275]

Moist Heat or Steam Sterilization

[04052536009275]

Moist Heat or Steam Sterilization

[04052536009275]

Moist Heat or Steam Sterilization

[04052536009275]

Moist Heat or Steam Sterilization

[04052536009275]

Moist Heat or Steam Sterilization

[04052536009275]

Moist Heat or Steam Sterilization

[04052536009275]

Moist Heat or Steam Sterilization

[04052536009275]

Moist Heat or Steam Sterilization

[04052536009275]

Moist Heat or Steam Sterilization

[04052536009275]

Moist Heat or Steam Sterilization

[04052536009275]

Moist Heat or Steam Sterilization

[04052536009275]

Moist Heat or Steam Sterilization

[04052536009275]

Moist Heat or Steam Sterilization

[04052536009275]

Moist Heat or Steam Sterilization

[04052536009275]

Moist Heat or Steam Sterilization

[04052536009275]

Moist Heat or Steam Sterilization

[04052536009275]

Moist Heat or Steam Sterilization

[04052536009275]

Moist Heat or Steam Sterilization

[04052536009275]

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 [ADD™ anterior distraction device]

• 04052536009275: ADD/Small VBR, ø 16 mm, height 24-40 mm, angle 6°
• 04052536009268: ADD/Small VBR, ø 16 mm, height 16-25 mm, angle 6°
• 04052536009251: ADD/Small VBR, ø 14 mm, height 39-65 mm, angle 6°
• 04052536009244: ADD/Small VBR, ø 14 mm, height 24-40 mm, angle 6°
• 04052536009237: ADD/Small VBR, ø 14 mm, height 16-25 mm, angle 6°
• 04052536009220: ADD/Small VBR, ø 12 mm, height 39-65 mm, angle 6°
• 04052536009213: ADD/Small VBR, ø 12 mm, height 24-40 mm, angle 6°
• 04052536009206: ADD/Small VBR, ø 12 mm, height 16-25 mm, angle 6°
• 04052536004416: ADD/Small VBR, ø 16 mm, height 24-40 mm, angle 0°
• 04052536004409: ADD/Small VBR, ø 16 mm, height 16-25 mm, angle 0°
• 04052536004393: ADD/Small VBR, ø 16 mm, height 12-17 mm, angle 0°
• 04052536004386: ADD/Small VBR, ø 16 mm, height 10-13 mm, angle 0°
• 04052536004379: ADD/Small VBR, ø 14 mm, height 39-65 mm, angle 0°
• 04052536004362: ADD/Small VBR, ø 14 mm, height 24-40 mm, angle 0°
• 04052536004355: ADD/Small VBR, ø 14 mm, height 16-25 mm, angle 0°
• 04052536004348: ADD/Small VBR, ø 14 mm, height 12-17 mm, angle 0°
• 04052536004331: ADD/Small VBR, ø 14 mm, height 10-13 mm, angle 0°
• 04052536004317: ADD/Small VBR, ø 12 mm, height 39-65 mm, angle 0°
• 04052536004294: ADD/Small VBR, ø 12 mm, height 24-40 mm, angle 0°
• 04052536004270: ADD/Small VBR, ø 12 mm, height 16-25 mm, angle 0°
• 04052536004263: ADD/Small VBR, ø 12 mm, height 12-17 mm, angle 0°
• 04052536004256: ADD/Small VBR, ø 12 mm, height 10-13 mm, angle 0°
• 04052536000029: ADD/Small VBR, ø 16 mm, height 39-65 mm, angle 0°