osmium™, ADDplus™ CS 1303-18

GUDID 04052536006854

osmium screw incl. bolt blue, Ø 4.0 mm, length 18 mm

Ulrich GmbH & Co. KG

Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 04052536006854
• NIH Device Record Key: 927dcba8-9037-426a-8c6a-6cdd3bfe3fbe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: osmium™, ADDplus™
• Version Model Number: CS 1303-18
• Catalog Number: CS 1303-18
• 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	04052536006854 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090841

FDA Product Code

• MQP: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Sterilization

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

[04052536006854]

Moist Heat or Steam Sterilization

[04052536006854]

Moist Heat or Steam Sterilization

[04052536006854]

Moist Heat or Steam Sterilization

[04052536006854]

Moist Heat or Steam Sterilization

[04052536006854]

Moist Heat or Steam Sterilization

[04052536006854]

Moist Heat or Steam Sterilization

[04052536006854]

Moist Heat or Steam Sterilization

[04052536006854]

Moist Heat or Steam Sterilization

[04052536006854]

Moist Heat or Steam Sterilization

[04052536006854]

Moist Heat or Steam Sterilization

[04052536006854]

Moist Heat or Steam Sterilization

[04052536006854]

Moist Heat or Steam Sterilization

[04052536006854]

Moist Heat or Steam Sterilization

[04052536006854]

Moist Heat or Steam Sterilization

[04052536006854]

Moist Heat or Steam Sterilization

[04052536006854]

Moist Heat or Steam Sterilization

[04052536006854]

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 [osmium™, ADDplus™]

• 04052536090570: osmium screw incl. bolt grey, Ø 4.0 mm, length 12 mm
• 04052536006854: osmium screw incl. bolt blue, Ø 4.0 mm, length 18 mm
• 04052536006847: osmium screw incl. bolt green, Ø 4.0 mm, length 16 mm
• 04052536006830: osmium screw incl. bolt gold, Ø 4.0 mm, length 14 mm
• 04052536002535: Cancellous bone screw, ø 4.0 mm, length 26 mm
• 04052536002528: Cancellous bone screw, ø 4.0 mm, length 24 mm
• 04052536002511: Cancellous bone screw, ø 4.0 mm, length 22 mm
• 04052536002504: Cancellous bone screw, ø 4.0 mm, length 20 mm
• 04052536002498: Cancellous bone screw, ø 4.0 mm, length 18 mm
• 04052536002481: Cancellous bone screw, ø 4.0 mm, length 16 mm
• 04052536002474: Cancellous bone screw, ø 4.0 mm, length 14 mm
• 04052536002467: Cancellous bone screw, ø 4.0 mm, length 12 mm
• 04052536002450: osmium screw incl. bolt, blue, ø 5.0 mm, length 18 mm
• 04052536002443: osmium screw incl. bolt, green, ø 5.0 mm, length 16 mm
• 04052536002436: osmium screw incl. bolt, gold, ø 5.0 mm, length 14 mm