VBR Omni™ vertebral body replacement CS 2250-26-7216

GUDID 04052536179183

VBR Omni, Ø 26 mm, height 72-131 mm, angle 16°

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 Vertebral body prosthesis

• Primary Device ID: 04052536179183
• NIH Device Record Key: f733ae40-7883-46df-8198-3703fe73e4de
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VBR Omni™ vertebral body replacement
• Version Model Number: CS 2250-26-7216
• Catalog Number: CS 2250-26-7216
• 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	04052536179183 [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

[04052536179183]

Moist Heat or Steam Sterilization

[04052536179183]

Moist Heat or Steam Sterilization

[04052536179183]

Moist Heat or Steam Sterilization

[04052536179183]

Moist Heat or Steam Sterilization

[04052536179183]

Moist Heat or Steam Sterilization

[04052536179183]

Moist Heat or Steam Sterilization

[04052536179183]

Moist Heat or Steam Sterilization

[04052536179183]

Moist Heat or Steam Sterilization

[04052536179183]

Moist Heat or Steam Sterilization

[04052536179183]

Moist Heat or Steam Sterilization

[04052536179183]

Moist Heat or Steam Sterilization

[04052536179183]

Moist Heat or Steam Sterilization

[04052536179183]

Moist Heat or Steam Sterilization

[04052536179183]

Moist Heat or Steam Sterilization

[04052536179183]

Moist Heat or Steam Sterilization

[04052536179183]

Moist Heat or Steam Sterilization

[04052536179183]

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: 2016-08-30

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°