ADD™ anterior distraction device CS 2250-16-24

GUDID 04052536004416

ADD/Small VBR, ø 16 mm, height 24-40 mm, angle 0°

Ulrich GmbH & Co. KG

Vertebral body prosthesis, non-sterile Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis Vertebral body prosthesis

• Primary Device ID: 04052536004416
• NIH Device Record Key: 4758f344-23bb-4bd4-8d96-6e9409dbd335
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ADD™ anterior distraction device
• Version Model Number: CS 2250-16-24
• Catalog Number: CS 2250-16-24
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04052536004416 [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

[04052536004416]

Moist Heat or Steam Sterilization

[04052536004416]

Moist Heat or Steam Sterilization

[04052536004416]

Moist Heat or Steam Sterilization

[04052536004416]

Moist Heat or Steam Sterilization

[04052536004416]

Moist Heat or Steam Sterilization

[04052536004416]

Moist Heat or Steam Sterilization

[04052536004416]

Moist Heat or Steam Sterilization

[04052536004416]

Moist Heat or Steam Sterilization

[04052536004416]

Moist Heat or Steam Sterilization

[04052536004416]

Moist Heat or Steam Sterilization

[04052536004416]

Moist Heat or Steam Sterilization

[04052536004416]

Moist Heat or Steam Sterilization

[04052536004416]

Moist Heat or Steam Sterilization

[04052536004416]

Moist Heat or Steam Sterilization

[04052536004416]

Moist Heat or Steam Sterilization

[04052536004416]

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°