neon³ CT spinal stabilization CS 3918-06-14

GUDID 04052536161683

Offset connector, parallel, right, length 14 mm

Ulrich GmbH & Co. KG

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 04052536161683
• NIH Device Record Key: 399e49f2-3435-4106-907d-e29dd1df273d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: neon³ CT spinal stabilization
• Version Model Number: CS 3918-06-14
• Catalog Number: CS 3918-06-14
• 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: +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	04052536161683 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150650

FDA Product Code

• NKG: Orthosis, cervical pedicle screw spinal fixation

Sterilization

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

[04052536161683]

Moist Heat or Steam Sterilization

[04052536161683]

Moist Heat or Steam Sterilization

[04052536161683]

Moist Heat or Steam Sterilization

[04052536161683]

Moist Heat or Steam Sterilization

[04052536161683]

Moist Heat or Steam Sterilization

[04052536161683]

Moist Heat or Steam Sterilization

[04052536161683]

Moist Heat or Steam Sterilization

[04052536161683]

Moist Heat or Steam Sterilization

[04052536161683]

Moist Heat or Steam Sterilization

[04052536161683]

Moist Heat or Steam Sterilization

[04052536161683]

Moist Heat or Steam Sterilization

[04052536161683]

Moist Heat or Steam Sterilization

[04052536161683]

Moist Heat or Steam Sterilization

[04052536161683]

Moist Heat or Steam Sterilization

[04052536161683]

Moist Heat or Steam Sterilization

[04052536161683]

Moist Heat or Steam Sterilization

[04052536161683]

Moist Heat or Steam Sterilization

[04052536161683]

Moist Heat or Steam Sterilization

[04052536161683]

Moist Heat or Steam Sterilization

[04052536161683]

Moist Heat or Steam Sterilization

[04052536161683]

Moist Heat or Steam Sterilization

[04052536161683]

Moist Heat or Steam Sterilization

[04052536161683]

Moist Heat or Steam Sterilization

[04052536161683]

Moist Heat or Steam Sterilization

[04052536161683]

Moist Heat or Steam Sterilization

[04052536161683]

Moist Heat or Steam Sterilization

[04052536161683]

Moist Heat or Steam Sterilization

[04052536161683]

Moist Heat or Steam Sterilization

[04052536161683]

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: 2016-09-22

On-Brand Devices [neon³ CT spinal stabilization]

• 04052536170012: Screwdriver, cannulated, with SR 15, coupling B
• 04052536168460: Rod, titanium alloy, Ø 4.0 mm, curved, length 120 mm
• 04052536168453: Rod, titanium alloy, Ø 4.0 mm, curved, length 110 mm
• 04052536168446: Rod, titanium alloy, Ø 4.0 mm, curved, length 100 mm
• 04052536168439: Rod, titanium alloy, Ø 4.0 mm, curved, length 90 mm
• 04052536168422: Rod, titanium alloy, Ø 4.0 mm, curved, length 80 mm
• 04052536168415: Rod, titanium alloy, Ø 4.0 mm, curved, length 70 mm
• 04052536168408: Rod, titanium alloy, Ø 4.0 mm, curved, length 60 mm
• 04052536168392: Rod, titanium alloy, Ø 4.0 mm, curved, length 55 mm
• 04052536168385: Rod, titanium alloy, Ø 4.0 mm, curved, length 50 mm
• 04052536168378: Rod, titanium alloy, Ø 4.0 mm, curved, length 45 mm
• 04052536168361: Rod, titanium alloy, Ø 4.0 mm, curved, length 40 mm
• 04052536168354: Rod, titanium alloy, Ø 4.0 mm, curved, length 35 mm
• 04052536168347: Rod, titanium alloy, Ø 4.0 mm, curved, length 30 mm
• 04052536168330: Rod, titanium alloy, Ø 4.0 mm, curved, length 25 mm
• 04052536167968: Rod, pure titanium, Ø 4.0 mm, length 200 mm
• 04052536162086: Adapter for injection
• 04052536161911: Reference star, for use with Brainlab
• 04052536161904: Drill guide
• 04052536161898: Sleeve for drill 2
• 04052536161881: Trocar, cannulated, for drill 2
• 04052536161874: Adapter for drill 2, serrated
• 04052536161850: Adapter for drill 1, serrated
• 04052536161843: Adapter for drill 1, blunt
• 04052536161829: Tap, cannulated, for screws Ø 5.5 mm, coupling B
• 04052536161812: Tap, for screws Ø 4.5 mm, coupling B
• 04052536161805: Tap, for screws Ø 4.0 mm, coupling B
• 04052536161799: Tap, for screws Ø 3.5 mm, coupling B
• 04052536161782: Cutter with handle, cannulated, Ø 3.0 mm
• 04052536161768: Offset connector, parallel, left, length 20 mm
• 04052536161751: Offset connector, parallel, left, length 17 mm
• 04052536161744: Offset connector, parallel, left, length 14 mm
• 04052536161737: Offset connector, parallel, left, length 11 mm
• 04052536161720: Offset connector, parallel, left, length 9 mm
• 04052536161713: Offset connector, parallel, left, length 7 mm
• 04052536161706: Offset connector, parallel, right, length 20 mm
• 04052536161690: Offset connector, parallel, right, length 17 mm
• 04052536161683: Offset connector, parallel, right, length 14 mm
• 04052536161676: Offset connector, parallel, right, length 11 mm
• 04052536161669: Offset connector, parallel, right, length 9 mm
• 04052536161652: Offset connector, parallel, right, length 7 mm
• 04052536161638: Offset connector, square, long
• 04052536161591: Crosslink, rod to rod, L, length 44 - 59 mm
• 04052536161584: Crosslink, rod to rod, M, length 39 - 49 mm
• 04052536161577: Crosslink, rod to rod, S, length 34 - 44 mm
• 04052536161447: Rod, titanium alloy, Ø 4.0 mm, length 200 mm
• 04052536161430: Rod, titanium alloy, Ø 4.0 mm, length 160 mm
• 04052536161423: Rod, titanium alloy, Ø 4.0 mm, length 140 mm
• 04052536161416: Rod, titanium alloy, Ø 4.0 mm, length 100 mm
• 04052536161409: Rod, titanium alloy, Ø 4.0 mm, length 95 mm