VBR Omni™ vertebral body replacement CS 2250-26-198

GUDID 04052536162352

VBR Omni, Ø 26 mm, height 19-29 mm, angle 8°

Ulrich GmbH & Co. KG

Vertebral body prosthesis, non-sterile

• Primary Device ID: 04052536162352
• NIH Device Record Key: bf460c85-7367-4119-8e5f-01ced71c9fe4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VBR Omni™ vertebral body replacement
• Version Model Number: CS 2250-26-198
• Catalog Number: CS 2250-26-198
• 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	04052536162352 [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

[04052536162352]

Moist Heat or Steam Sterilization

[04052536162352]

Moist Heat or Steam Sterilization

[04052536162352]

Moist Heat or Steam Sterilization

[04052536162352]

Moist Heat or Steam Sterilization

[04052536162352]

Moist Heat or Steam Sterilization

[04052536162352]

Moist Heat or Steam Sterilization

[04052536162352]

Moist Heat or Steam Sterilization

[04052536162352]

Moist Heat or Steam Sterilization

[04052536162352]

Moist Heat or Steam Sterilization

[04052536162352]

Moist Heat or Steam Sterilization

[04052536162352]

Moist Heat or Steam Sterilization

[04052536162352]

Moist Heat or Steam Sterilization

[04052536162352]

Moist Heat or Steam Sterilization

[04052536162352]

Moist Heat or Steam Sterilization

[04052536162352]

Moist Heat or Steam Sterilization

[04052536162352]

Moist Heat or Steam Sterilization

[04052536162352]

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 [VBR Omni™ vertebral body replacement]

• 04052536179282: VBR Omni, Ø 30mm, height 72-131 mm, angle 8°
• 04052536179275: VBR Omni, Ø 30mm, height 72-131 mm, angle 22°
• 04052536179268: VBR Omni, Ø 30mm, height 72-131 mm, angle 16°
• 04052536179251: VBR Omni, Ø 30mm, height 72-131 mm, angle 12°
• 04052536179244: VBR Omni, Ø 30mm, height 46-80 mm, angle 4°
• 04052536179237: VBR Omni, Ø 30 mm, height 46-80 mm, angle 16°
• 04052536179220: VBR Omni, Ø 30mm, height 46-80 mm, angle 12°
• 04052536179213: VBR Omni, Ø 30 mm, height 32-53 mm, angle 4°
• 04052536179206: VBR Omni, Ø 30mm, height 32-53 mm, angle 12°
• 04052536179190: VBR Omni, Ø 26 mm, height 72-131 mm, angle 20°
• 04052536179183: VBR Omni, Ø 26 mm, height 72-131 mm, angle 16°
• 04052536179176: VBR Omni, Ø 26 mm, height 46-80 mm, angle 4°
• 04052536179169: VBR Omni, Ø 26 mm, height 46-80 mm, angle 12°
• 04052536179152: VBR Omni, Ø 26 mm, height 32-53 mm, angle 4°
• 04052536179145: VBR Omni, Ø 26 mm, height 32-53 mm, angle 12°
• 04052536179138: VBR Omni, Ø 26 mm, height 24-38 mm, angle 4°
• 04052536179121: VBR Omni, Ø 26 mm, height 19-29 mm, angle 4°
• 04052536179114: VBR Omni, Ø 22 mm, Höhe 72-131 mm, angle 16°
• 04052536179107: VBR Omni, Ø 22 mm, height 46-80 mm, angle 4°
• 04052536179091: VBR Omni, Ø 22 mm, height 46-80 mm, angle 12°
• 04052536179084: VBR Omni, Ø 22 mm, height 32-53 mm, angle 4°
• 04052536179077: VBR Omni, Ø 22 mm, height 32-53 mm, angle 12°
• 04052536179060: VBR Omni, Ø 22 mm, height 24-38 mm, angle 4°
• 04052536179053: VBR Omni, Ø 22 mm, Höhe 19-29 mm, angle 4°
• 04052536179046: VBR Omni, Ø 19 mm, height 72-131 mm, angle 4°
• 04052536179039: VBR Omni, Ø 19 mm, height 72-131 mm, angle 8°
• 04052536179022: VBR Omni, Ø 19 mm, height 46-80 mm, angle 8°
• 04052536179015: VBR Omni, Ø 19 mm, height 32-53 mm, angle 8°
• 04052536179008: VBR Omni, Ø 19 mm, height 24-38 mm, angle 4°
• 04052536178995: VBR Omni, Ø 19 mm, height 19-29 mm, angle 4°
• 04052536178988: VBR Omni, Ø 19 mm, height 15-22 mm, angle 4°
• 04052536178971: VBR Omni, Ø 19 mm, height 15-22 mm, angle 0°
• 04052536178964: VBR Omni, Ø 19 mm, height 10-13 mm, angle 0°
• 04052536162444: VBR Omni, Ø 30 mm, height 46-80 mm, angle 8°
• 04052536162437: VBR Omni, Ø 30 mm, height 32-53 mm, angle 8°
• 04052536162420: VBR Omni, Ø 30 mm, height 32-53 mm, angle 0°
• 04052536162413: VBR Omni, Ø 26 mm, height 46-80 mm, angle 8°
• 04052536162406: VBR Omni, Ø 26 mm, height 46-80 mm, angle 16°
• 04052536162390: VBR Omni, Ø 26 mm, height 32-53 mm, angle 8°
• 04052536162383: VBR Omni, Ø 26 mm, height 32-53 mm, angle 0°
• 04052536162376: VBR Omni, Ø 26 mm, height 24-38 mm, angle 8°
• 04052536162369: VBR Omni, Ø 26 mm, height 24-38 mm, angle 0°
• 04052536162352: VBR Omni, Ø 26 mm, height 19-29 mm, angle 8°
• 04052536162345: VBR Omni, Ø 26 mm, height 19-29 mm, angle 0°
• 04052536162338: VBR Omni, Ø 22 mm, height 46-80 mm, angle 8°
• 04052536162321: VBR Omni, Ø 22 mm, height 32-53 mm, angle 8°
• 04052536162314: VBR Omni, Ø 22 mm, height 32-53 mm, angle 0°
• 04052536162307: VBR Omni, Ø 22 mm, height 24-38 mm, angle 0°
• 04052536162291: VBR Omni, Ø 22 mm, height 19-29 mm, angle 0°
• 04052536162284: VBR Omni, Ø 19 mm, height 46-80 mm, angle 0°