NEON 3 CS 3913-55-10

GUDID 04052536192540

Occipital screw, Ø 5.5 mm, length 10 mm, self-tapping

Ulrich GmbH & Co. KG

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 04052536192540
• NIH Device Record Key: 4a7ba50b-13c2-4206-97c3-11f3cc2dfacb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NEON 3
• Version Model Number: CS 3913-55-10
• Catalog Number: CS 3913-55-10
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04052536192540 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161032

FDA Product Code

• NKG: Orthosis, cervical pedicle screw spinal fixation

Sterilization

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

[04052536192540]

Moist Heat or Steam Sterilization

[04052536192540]

Moist Heat or Steam Sterilization

[04052536192540]

Moist Heat or Steam Sterilization

[04052536192540]

Moist Heat or Steam Sterilization

[04052536192540]

Moist Heat or Steam Sterilization

[04052536192540]

Moist Heat or Steam Sterilization

[04052536192540]

Moist Heat or Steam Sterilization

[04052536192540]

Moist Heat or Steam Sterilization

[04052536192540]

Moist Heat or Steam Sterilization

[04052536192540]

Moist Heat or Steam Sterilization

[04052536192540]

Moist Heat or Steam Sterilization

[04052536192540]

Moist Heat or Steam Sterilization

[04052536192540]

Moist Heat or Steam Sterilization

[04052536192540]

Moist Heat or Steam Sterilization

[04052536192540]

Moist Heat or Steam Sterilization

[04052536192540]

Moist Heat or Steam Sterilization

[04052536192540]

Moist Heat or Steam Sterilization

[04052536192540]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-03-11
• Device Publish Date: 2019-02-28

On-Brand Devices [NEON 3]

• 04052536192571: Occipital screw, Ø 5.5 mm, length 16 mm, self-tapping
• 04052536192564: Occipital screw, Ø 5.5 mm, length 14 mm, self-tapping
• 04052536192557: Occipital screw, Ø 5.5 mm, length 12 mm, self-tapping
• 04052536192540: Occipital screw, Ø 5.5 mm, length 10 mm, self-tapping
• 04052536192533: Occipital screw, Ø 5.5 mm, length 8 mm, self-tapping
• 04052536192526: Occipital screw, Ø 5.5 mm, length 6 mm, self-tapping