mambo™ modular cervical plate system CS 1826-01

GUDID 04052536008308

mambo settling screw grey

Ulrich GmbH & Co. KG

Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 04052536008308
• NIH Device Record Key: a84f424a-1464-4731-b9ed-8c00a94867d9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: mambo™ modular cervical plate system
• Version Model Number: CS 1826-01
• Catalog Number: CS 1826-01
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04052536008308 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090861

FDA Product Code

• KWQ: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Sterilization

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

[04052536008308]

Moist Heat or Steam Sterilization

[04052536008308]

Moist Heat or Steam Sterilization

[04052536008308]

Moist Heat or Steam Sterilization

[04052536008308]

Moist Heat or Steam Sterilization

[04052536008308]

Moist Heat or Steam Sterilization

[04052536008308]

Moist Heat or Steam Sterilization

[04052536008308]

Moist Heat or Steam Sterilization

[04052536008308]

Moist Heat or Steam Sterilization

[04052536008308]

Moist Heat or Steam Sterilization

[04052536008308]

Moist Heat or Steam Sterilization

[04052536008308]

Moist Heat or Steam Sterilization

[04052536008308]

Moist Heat or Steam Sterilization

[04052536008308]

Moist Heat or Steam Sterilization

[04052536008308]

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 [mambo™ modular cervical plate system]

• 04052536164400: mambo bone screw, self-drilling, violet, Ø 3.5 mm, length 19 mm
• 04052536164394: mambo bone screw, self-drilling, violet, Ø 3.5 mm, length 17 mm
• 04052536164387: mambo bone screw, self-drilling, violet, Ø 3.5 mm, length 15 mm
• 04052536164370: mambo bone screw, self-drilling, violet, Ø 3.5 mm, length 13 mm
• 04052536090587: CS 1818-52
• 04052536008452: mambo rescue screw yellow, ø 4 mm, length 19 mm
• 04052536008438: mambo rescue screw yellow, ø 4 mm, length 17 mm
• 04052536008414: mambo rescue screw yellow, ø 4 mm, length 15 mm
• 04052536008391: mambo rescue screw yellow, ø 4 mm, length 13 mm
• 04052536008384: mambo bone screw, self drilling, grey, Ø 3.5 mm, length 19 mm
• 04052536008360: mambo bone screw, self drilling, grey, Ø 3.5 mm, length 17 mm
• 04052536008346: mambo bone screw, self drilling, grey, Ø 3.5 mm, length 15 mm
• 04052536008322: mambo bone screw, self drilling, grey, Ø 3.5 mm, length 13 mm
• 04052536008315: mambo clamping screw yellow
• 04052536008308: mambo settling screw grey
• 04052536008278: mambo plate L blue, 6-hole, length 50 mm
• 04052536008261: mambo plate L blue, 4-hole, length 29 mm
• 04052536008254: mambo caudal plate L blue
• 04052536008247: mambo extension plate L blue
• 04052536008230: mambo cranial plate L blue
• 04052536008209: mambo plate M green, 6-hole, length 45 mm
• 04052536008193: mambo plate M green, 4-hole, length 26 mm
• 04052536008186: mambo caudal plate M green
• 04052536008179: mambo extension plate M green
• 04052536008162: mambo cranial plate M green
• 04052536008131: mambo plate S yellow, 6-hole, length 40 mm
• 04052536008124: mambo plate S yellow, 4-hole, length 24 mm
• 04052536008117: mambo single plate XS yellow, length 22 mm
• 04052536008100: mambo single plate XXS yellow, length 20 mm
• 04052536008094: mambo caudal plate S yellow
• 04052536008087: mambo extension plate S yellow
• 04052536008070: mambo cranial plate S yellow
• 04052536008063: mambo plate XS violet, 6-hole, length 37 mm
• 04052536008056: mambo plate XS violet, 4-hole, length 22 mm
• 04052536008049: mambo caudal plate XS violet
• 04052536008032: mambo extension plate XS violet
• 04052536008025: mambo cranial plate XS violet