ADD

GUDID 04052536009503

Layer for ADD/small VBR implants

Ulrich GmbH & Co. KG

Device sterilization/disinfection container, reusable

• Primary Device ID: 04052536009503
• NIH Device Record Key: f10782c6-873e-4087-b2e4-a193ded571bd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ADD
• Version Model Number: CS 2258-1
• Company DUNS: 315494757
• Company Name: Ulrich GmbH & Co. KG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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: + 4973196540
• Email: safety@ulrichmedical.com
• Phone: + 4973196540
• Email: safety@ulrichmedical.com
• Phone: + 4973196540
• Email: safety@ulrichmedical.com
• Phone: + 4973196540
• Email: safety@ulrichmedical.com
• Phone: + 4973196540
• Email: safety@ulrichmedical.com
• Phone: + 4973196540
• Email: safety@ulrichmedical.com
• Phone: + 4973196540
• Email: safety@ulrichmedical.com
• Phone: + 4973196540
• Email: safety@ulrichmedical.com
• Phone: + 4973196540
• Email: safety@ulrichmedical.com
• Phone: + 4973196540
• Email: safety@ulrichmedical.com
• Phone: + 4973196540
• Email: safety@ulrichmedical.com
• Phone: + 4973196540
• Email: safety@ulrichmedical.com
• Phone: + 4973196540
• Email: safety@ulrichmedical.com
• Phone: + 4973196540
• Email: safety@ulrichmedical.com
• Phone: + 4973196540
• Email: safety@ulrichmedical.com
• Phone: + 4973196540
• Email: safety@ulrichmedical.com
• Phone: + 4973196540
• Email: safety@ulrichmedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04052536009503 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192117

FDA Product Code

• MQP: Spinal Vertebral Body Replacement Device

Sterilization

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

[04052536009503]

Moist Heat or Steam Sterilization

[04052536009503]

Moist Heat or Steam Sterilization

[04052536009503]

Moist Heat or Steam Sterilization

[04052536009503]

Moist Heat or Steam Sterilization

[04052536009503]

Moist Heat or Steam Sterilization

[04052536009503]

Moist Heat or Steam Sterilization

[04052536009503]

Moist Heat or Steam Sterilization

[04052536009503]

Moist Heat or Steam Sterilization

[04052536009503]

Moist Heat or Steam Sterilization

[04052536009503]

Moist Heat or Steam Sterilization

[04052536009503]

Moist Heat or Steam Sterilization

[04052536009503]

Moist Heat or Steam Sterilization

[04052536009503]

Moist Heat or Steam Sterilization

[04052536009503]

Moist Heat or Steam Sterilization

[04052536009503]

Moist Heat or Steam Sterilization

[04052536009503]

Moist Heat or Steam Sterilization

[04052536009503]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-11-06
• Device Publish Date: 2024-10-29

On-Brand Devices [ADD]

• 04052536076789: VBR lollipop trial, Ø 16 mm/20 mm
• 04052536009671: Measuring template for ADD/small VBR
• 04052536009510: Layer for ADD/small VBR instruments
• 04052536009503: Layer for ADD/small VBR implants
• 04052536219605: Layer for ADD/small VBR instruments
• 04052536219599: Layer for ADD/small VBR implants