obeliscPRO™ vertebral body replacement CS 2916-00

GUDID 04052536113781

obelisc lateral end piece, blue, length 55 mm, angle 0°

Ulrich GmbH & Co. KG

Vertebral body prosthesis, non-sterile

• Primary Device ID: 04052536113781
• NIH Device Record Key: af0fe80f-b38a-4ec6-a90f-9b6613db165e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: obeliscPRO™ vertebral body replacement
• Version Model Number: CS 2916-00
• Catalog Number: CS 2916-00
• 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	04052536113781 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060416

FDA Product Code

• MQP: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Sterilization

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

[04052536113781]

Moist Heat or Steam Sterilization

[04052536113781]

Moist Heat or Steam Sterilization

[04052536113781]

Moist Heat or Steam Sterilization

[04052536113781]

Moist Heat or Steam Sterilization

[04052536113781]

Moist Heat or Steam Sterilization

[04052536113781]

Moist Heat or Steam Sterilization

[04052536113781]

Moist Heat or Steam Sterilization

[04052536113781]

Moist Heat or Steam Sterilization

[04052536113781]

Moist Heat or Steam Sterilization

[04052536113781]

Moist Heat or Steam Sterilization

[04052536113781]

Moist Heat or Steam Sterilization

[04052536113781]

Moist Heat or Steam Sterilization

[04052536113781]

Moist Heat or Steam Sterilization

[04052536113781]

Moist Heat or Steam Sterilization

[04052536113781]

Moist Heat or Steam Sterilization

[04052536113781]

Moist Heat or Steam Sterilization

[04052536113781]

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 [obeliscPRO™ vertebral body replacement]

• 04052536162963: Shaft flexible for screwdriver, hex 3.5 mm
• 04052536162956: Locking rod flexible, length 450 mm
• 04052536162949: Expansion rod flexible, length 450 mm
• 04052536162932: Holder curved, length 450 mm
• 04052536113811: obelisc lateral end piece, blue, length 55 mm, angle 15°
• 04052536113804: obelisc lateral end piece, blue, length 55 mm, angle 10°
• 04052536113798: obelisc lateral end piece, blue, length 55 mm, angle 5°
• 04052536113781: obelisc lateral end piece, blue, length 55 mm, angle 0°
• 04052536113774: obelisc lateral end piece, green, length 45 mm, angle 15°
• 04052536113767: obelisc lateral end piece, green, length 45 mm, angle 10°
• 04052536113750: obelisc lateral end piece, green, length 45 mm, angle 5°
• 04052536113743: obelisc lateral end piece, green, length 45 mm, angle 0°
• 04052536113736: obelisc lateral end piece, yellow, length 35 mm, angle 15°
• 04052536113729: obelisc lateral end piece, yellow, length 35 mm, angle 10°
• 04052536113712: obelisc lateral end piece, yellow, length 35 mm, angle 5°
• 04052536113705: obelisc lateral end piece, yellow, length 35 mm, angle 0°