krypton™, tangoRS™ CS 2809-4T

GUDID 04052536005543

Nut for crosslink

Ulrich GmbH & Co. KG

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 04052536005543
• NIH Device Record Key: 9d351461-f165-4dad-b718-43f4691b5ac6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: krypton™, tangoRS™
• Version Model Number: CS 2809-4T
• Catalog Number: CS 2809-4T
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04052536005543 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120891

FDA Product Code

• MNI: ORTHOSIS, SPINAL PEDICLE FIXATION

Sterilization

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

[04052536005543]

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 [krypton™, tangoRS™]

• 04052536005550: Locking plate for crosslink
• 04052536005543: Nut for crosslink
• 04052536005529: X-plate for crosslink, length 65 mm
• 04052536005512: X-plate for crosslink, length 50 mm