QUIKFLAP, UNIVERSAL NEURO 2 12-01502

GUDID 07613154619849

2 HOLE PLATES(3) SELF DRILLING SCREW(6)

Stryker Leibinger GmbH & Co. KG

Craniofacial fixation plate kit, non-bioabsorbable

• Primary Device ID: 07613154619849
• NIH Device Record Key: af8ec0f6-f1bb-431f-8398-1ad99aac2978
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QUIKFLAP, UNIVERSAL NEURO 2
• Version Model Number: 12-01502
• Catalog Number: 12-01502
• Company DUNS: 316153956
• Company Name: Stryker Leibinger GmbH & Co. KG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613154619849 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K862482

FDA Product Code

• JEY: PLATE, BONE

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-24

On-Brand Devices [QUIKFLAP, UNIVERSAL NEURO 2]

• 07613154619849: 2 HOLE PLATES(3) SELF DRILLING SCREW(6)
• 04546540491145: LOW PROFILE BURR HOLE COVER, W/TAB,20mm
• 04546540491138: LOW PROFILE BURR HOLE COVER, W/TAB, 14mm
• 04546540491121: LOW PROFILE BURR HOLE COVER, W/TAB, 10mm
• 04546540491114: LOW PROFILE BURR HOLE COVER, W/TAB, 7mm