ADDplus™, ADD™, VBR™, topaz™ CS 2259

GUDID 04052536004461

Locking screw

Ulrich GmbH & Co. KG

Vertebral body prosthesis, non-sterile

• Primary Device ID: 04052536004461
• NIH Device Record Key: 1a967922-0731-4fef-a369-78b46789de9a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ADDplus™, ADD™, VBR™, topaz™
• Version Model Number: CS 2259
• Catalog Number: CS 2259
• 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	04052536004461 [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

[04052536004461]

Moist Heat or Steam Sterilization

[04052536004461]

Moist Heat or Steam Sterilization

[04052536004461]

Moist Heat or Steam Sterilization

[04052536004461]

Moist Heat or Steam Sterilization

[04052536004461]

Moist Heat or Steam Sterilization

[04052536004461]

Moist Heat or Steam Sterilization

[04052536004461]

Moist Heat or Steam Sterilization

[04052536004461]

Moist Heat or Steam Sterilization

[04052536004461]

Moist Heat or Steam Sterilization

[04052536004461]

Moist Heat or Steam Sterilization

[04052536004461]

Moist Heat or Steam Sterilization

[04052536004461]

Moist Heat or Steam Sterilization

[04052536004461]

Moist Heat or Steam Sterilization

[04052536004461]

Moist Heat or Steam Sterilization

[04052536004461]

Moist Heat or Steam Sterilization

[04052536004461]

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

Devices Manufactured by Ulrich GmbH & Co. KG

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• 04052536009510 - ADD: 2024-11-06 Layer for ADD/small VBR instruments
• 04052536009671 - ADD: 2024-11-06 Measuring template for ADD/small VBR
• 04052536076789 - ADD: 2024-11-06 VBR lollipop trial, Ø 16 mm/20 mm
• 04052536166466 - ulrich medical disposables: 2024-06-06 Patient tubing, 250 cm for ulricheasyINJECT CT/MRT injectors
• 04052536166480 - ulrich medical disposables: 2024-06-06 Patient tubing, 320 cm for ulricheasyINJECT CT/MRT injectors
• 04052536175147 - ulrich medical disposables: 2024-06-06 Easy-Click-Cassette 3 - flex for ulricheasyINJECT CT/MRI injectors
• 04052536175239 - ulrich medical disposables: 2024-06-06 Easy-Click-Cassette 2M - flex for ulricheasyINJECT CT/MRI injectors