UNIVERSAL NEURO 2, QUIKFLAP 53-05804

GUDID 04546540394118

Low Profile Plate, straight

Stryker Leibinger GmbH & Co. KG

Craniofacial fixation plate, non-bioabsorbable

• Primary Device ID: 04546540394118
• NIH Device Record Key: 1ebaea9a-6405-4c01-aba3-9299a1f6a55d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UNIVERSAL NEURO 2, QUIKFLAP
• Version Model Number: 53-05804
• Catalog Number: 53-05804
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	04546540394118 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K031659

FDA Product Code

• JEY: PLATE, BONE

Sterilization

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

[04546540394118]

Moist Heat or Steam Sterilization

[04546540394118]

Moist Heat or Steam Sterilization

[04546540394118]

Moist Heat or Steam Sterilization

[04546540394118]

Moist Heat or Steam Sterilization

[04546540394118]

Moist Heat or Steam Sterilization

[04546540394118]

Moist Heat or Steam Sterilization

[04546540394118]

Moist Heat or Steam Sterilization

[04546540394118]

Moist Heat or Steam Sterilization

[04546540394118]

Moist Heat or Steam Sterilization

[04546540394118]

Moist Heat or Steam Sterilization

[04546540394118]

Moist Heat or Steam Sterilization

[04546540394118]

Moist Heat or Steam Sterilization

[04546540394118]

Moist Heat or Steam Sterilization

[04546540394118]

Moist Heat or Steam Sterilization

[04546540394118]

Moist Heat or Steam Sterilization

[04546540394118]

Moist Heat or Steam Sterilization

[04546540394118]

Moist Heat or Steam Sterilization

[04546540394118]

Moist Heat or Steam Sterilization

[04546540394118]

Moist Heat or Steam Sterilization

[04546540394118]

Moist Heat or Steam Sterilization

[04546540394118]

Moist Heat or Steam Sterilization

[04546540394118]

Moist Heat or Steam Sterilization

[04546540394118]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-07-01
• Device Publish Date: 2015-09-24

On-Brand Devices [UNIVERSAL NEURO 2, QUIKFLAP]

• 04546540394125: Plate, rigid
• 04546540394118: Low Profile Plate, straight
• 37613154481775: NEURO SCREWS,CROSS-PIN,SELF-DRILLING
• 37613154481768: NEURO SCREWS,CROSS-PIN,SELF-TAPPING
• 37613154481751: NEURO SCREWS,CROSS-PIN,SELF-TAPPING
• 37613154481744: NEURO SCREWS,CROSS-PIN,SELF-TAPPING