pezo-T™ PEEK cage family CS 3317-09

GUDID 04052536016297

pezo-T, height 9 mm, length x width 34 x 16 mm, angle 5°

Ulrich GmbH & Co. KG

Polymeric spinal fusion cage, sterile

• Primary Device ID: 04052536016297
• NIH Device Record Key: 2734e088-6b36-473f-aa09-7f5a6fdc8c4e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: pezo-T™ PEEK cage family
• Version Model Number: CS 3317-09
• Catalog Number: CS 3317-09
• 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
• 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	04052536016297 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103814

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

Sterilization

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

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 [pezo-T™ PEEK cage family]

• 04052536016396: pezo-T, height 14 mm, length x width 34 x 16 mm, angle 5°
• 04052536016372: pezo-T, height 13 mm, length x width 34 x 16 mm, angle 5°
• 04052536016358: pezo-T, height 12 mm, length x width 34 x 16 mm, angle 5°
• 04052536016334: pezo-T, height 11 mm, length x width 34 x 16 mm, angle 5°
• 04052536016310: pezo-T, height 10 mm, length x width 34 x 16 mm, angle 5°
• 04052536016297: pezo-T, height 9 mm, length x width 34 x 16 mm, angle 5°
• 04052536016273: pezo-T, height 8 mm, length x width 34 x 16 mm, angle 5°
• 04052536016259: pezo-T, height 7 mm, length x width 34 x 16 mm, angle 5°
• 04052536016235: pezo-T, height 14 mm, length x width 29 x 14 mm, angle 5°
• 04052536016211: pezo-T, height 13 mm, length x width 29 x 14 mm, angle 5°
• 04052536016198: pezo-T, height 12 mm, length x width 29 x 14 mm, angle 5°
• 04052536016174: pezo-T, height 11 mm, length x width 29 x 14 mm, angle 5°
• 04052536016167: pezo-T, height 10 mm, length x width 29 x 14 mm, angle 5°
• 04052536016143: pezo-T, height 9 mm, length x width 29 x 14 mm, angle 5°
• 04052536016129: pezo-T, height 8 mm, length x width 29 x 14 mm, angle 5°
• 04052536016105: pezo-T, height 7 mm, length x width 29 x 14 mm, angle 5°
• 04052536016082: pezo-T, height 14 mm, length x width 29 x 11 mm, angle 5°
• 04052536016075: pezo-T, height 13 mm, length x width 29 x 11 mm, angle 5°
• 04052536016051: pezo-T, height 12 mm, length x width 29 x 11 mm, angle 5°
• 04052536016037: pezo-T, height 11 mm, length x width 29 x 11 mm, angle 5°
• 04052536016013: pezo-T, height 10 mm, length x width 29 x 11 mm, angle 5°
• 04052536015993: pezo-T, height 9 mm, length x width 29 x 11 mm, angle 5°
• 04052536015979: pezo-T, height 8 mm, length x width 29 x 11 mm, angle 5°
• 04052536015955: pezo-T, height 7 mm, length x width 29 x 11 mm, angle 5°