uCentum™ comprehensive posterior system CS 3802-055-040

GUDID 04052536078769

Screw, polyaxial, Ø 5.5 mm, length 40 mm perforated

Ulrich GmbH & Co. KG

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 04052536078769
• NIH Device Record Key: 679b7f81-1c24-4c7c-be3d-7a07ced08655
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: uCentum™ comprehensive posterior system
• Version Model Number: CS 3802-055-040
• Catalog Number: CS 3802-055-040
• 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	04052536078769 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123717

FDA Product Code

• MNH: Orthosis, spondylolisthesis spinal fixation

Sterilization

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

[04052536078769]

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 [uCentum™ comprehensive posterior system]

• 04052536169900: Crosslink with hook, variable, XL, length 83 - 106 mm
• 04052536169894: Crosslink with hook, variable, L, length 60 - 85 mm
• 04052536169887: Crosslink with hook, variable, M, length 52 - 62 mm
• 04052536169870: Crosslink with hook, variable, XS, length 35 - 46 mm
• 04052536169863: Crosslink with hook, variable, S, length 44 - 54 mm
• 04052536169368: Screw, pre-fixation, Ø 4,5 mm, length 50 mm, not cannulated
• 04052536169351: Screw, pre-fixation, Ø 4,5 mm, length 45 mm, not cannulated
• 04052536169337: Screw, pre-fixation, Ø 4,5 mm, length 40 mm, not cannulated
• 04052536169320: Screw, pre-fixation, Ø 4,5 mm, length 35 mm, not cannulated
• 04052536169313: Screw, pre-fixation, Ø 4,5 mm, length 30 mm, not cannulated
• 04052536169306: Screw, pre-fixation, Ø 4,5 mm, length 25 mm, not cannulated
• 04052536169245: Screw, polyaxial, Ø 4.5 mm, length 50 mm, not cannulated
• 04052536169238: Screw, polyaxial, Ø 4.5 mm, length 45 mm, not cannulated
• 04052536169221: Screw, polyaxial, Ø 4.5 mm, length 40 mm, not cannulated
• 04052536169214: Screw, polyaxial, Ø 4.5 mm, length 35 mm, not cannulated
• 04052536169207: Screw, polyaxial, Ø 4.5 mm, length 30 mm, not cannulated
• 04052536169191: Screw, polyaxial, Ø 4.5 mm, length 25 mm, not cannulated
• 04052536083275: Longarm screw, polyaxial, Ø 8.5 mm, length 60 mm, not cannulated
• 04052536083268: Longarm screw, polyaxial, Ø 8.5 mm, length 55 mm, not cannulated
• 04052536083251: Longarm screw, polyaxial, Ø 8.5 mm, length 50 mm, not cannulated
• 04052536083244: Longarm screw, polyaxial, Ø 8.5 mm, length 45 mm, not cannulated
• 04052536083237: Longarm screw, polyaxial, Ø 8.5 mm, length 40 mm, not cannulated
• 04052536083220: Longarm screw, polyaxial, Ø 8.5 mm, length 35 mm, not cannulated
• 04052536083213: Longarm screw, polyaxial, Ø 7.5 mm, length 60 mm, not cannulated
• 04052536083206: Longarm screw, polyaxial, Ø 7.5 mm, length 55 mm, not cannulated
• 04052536083190: Longarm screw, polyaxial, Ø 7.5 mm, length 50 mm, not cannulated
• 04052536083183: Longarm screw, polyaxial, Ø 7.5 mm, length 45 mm, not cannulated
• 04052536083176: Longarm screw, polyaxial, Ø 7.5 mm, length 40 mm, not cannulated
• 04052536083169: Longarm screw, polyaxial, Ø 7.5 mm, length 35 mm, not cannulated
• 04052536083152: Longarm screw, polyaxial, Ø 6.5 mm, length 60 mm, not cannulated
• 04052536083145: Longarm screw, polyaxial, Ø 6.5 mm, length 55 mm, not cannulated
• 04052536083138: Longarm screw, polyaxial, Ø 6.5 mm, length 50 mm, not cannulated
• 04052536083121: Longarm screw, polyaxial, Ø 6.5 mm, length 45 mm, not cannulated
• 04052536083114: Longarm screw, polyaxial, Ø 6.5 mm, length 40 mm, not cannulated
• 04052536083107: Longarm screw, polyaxial, Ø 6.5 mm, length 35 mm, not cannulated
• 04052536083091: Longarm screw, polyaxial, Ø 6.5 mm, length 30 mm, not cannulated
• 04052536083084: Longarm screw, polyaxial, Ø 5.5 mm, length 55 mm, not cannulated
• 04052536083077: Longarm screw, polyaxial, Ø 5.5 mm, length 50 mm, not cannulated
• 04052536083060: Longarm screw, polyaxial, Ø 5.5 mm, length 45 mm, not cannulated
• 04052536083053: Longarm screw, polyaxial, Ø 5.5 mm, length 40 mm, not cannulated
• 04052536083046: Longarm screw, polyaxial, Ø 5.5 mm, length 35 mm, not cannulated
• 04052536083039: Longarm screw, polyaxial, Ø 5.5 mm, length 30 mm, not cannulated
• 04052536083022: Longarm screw, polyaxial, Ø 5.5 mm, length 25 mm, not cannulated
• 04052536083015: Screw, pre-fixation, Ø 10.0 mm, length 60 mm, not cannulated
• 04052536083008: Screw, pre-fixation, Ø 10.0 mm, length 55 mm, not cannulated
• 04052536082995: Screw, pre-fixation, Ø 10.0 mm, length 50 mm, not cannulated
• 04052536082988: Screw, pre-fixation, Ø 10.0 mm, length 45 mm, not cannulated
• 04052536082971: Screw, pre-fixation, Ø 8.5 mm, length 60 mm, not cannulated
• 04052536082964: Screw, pre-fixation, Ø 8.5 mm, length 55 mm, not cannulated
• 04052536082957: Screw, pre-fixation, Ø 8.5 mm, length 50 mm, not cannulated