UNIVERSAL NEURO 2, UNIVERSAL NEURO III 54-00346

GUDID 04546540237606

DYNAMIC MESH MALL. F. 1.5/1.7MM SCREWS

Stryker Leibinger GmbH & Co. KG

Craniofacial fixation plate, non-bioabsorbable

• Primary Device ID: 04546540237606
• NIH Device Record Key: 36ca7fa0-391f-4445-a426-6c76997d05cb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UNIVERSAL NEURO 2, UNIVERSAL NEURO III
• Version Model Number: 54-00346
• Catalog Number: 54-00346
• 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
• Width: 90 Millimeter
• Length: 90 Millimeter
• Device Size Text, specify: 0
• Width: 90 Millimeter
• Length: 90 Millimeter
• Device Size Text, specify: 0
• Width: 90 Millimeter
• Length: 90 Millimeter
• Device Size Text, specify: 0
• Width: 90 Millimeter
• Length: 90 Millimeter
• Device Size Text, specify: 0
• Width: 90 Millimeter
• Length: 90 Millimeter
• Device Size Text, specify: 0
• Width: 90 Millimeter
• Length: 90 Millimeter
• Device Size Text, specify: 0
• Width: 90 Millimeter
• Length: 90 Millimeter
• Device Size Text, specify: 0
• Width: 90 Millimeter
• Length: 90 Millimeter
• Device Size Text, specify: 0
• Width: 90 Millimeter
• Length: 90 Millimeter
• Device Size Text, specify: 0
• Width: 90 Millimeter
• Length: 90 Millimeter
• Device Size Text, specify: 0
• Width: 90 Millimeter
• Length: 90 Millimeter
• Device Size Text, specify: 0
• Width: 90 Millimeter
• Length: 90 Millimeter
• Device Size Text, specify: 0
• Width: 90 Millimeter
• Length: 90 Millimeter
• Device Size Text, specify: 0
• Width: 90 Millimeter
• Length: 90 Millimeter
• Device Size Text, specify: 0
• Width: 90 Millimeter
• Length: 90 Millimeter
• Device Size Text, specify: 0
• Width: 90 Millimeter
• Length: 90 Millimeter
• Device Size Text, specify: 0
• Width: 90 Millimeter
• Length: 90 Millimeter
• Device Size Text, specify: 0
• Width: 90 Millimeter
• Length: 90 Millimeter
• Device Size Text, specify: 0
• Width: 90 Millimeter
• Length: 90 Millimeter
• Device Size Text, specify: 0
• Width: 90 Millimeter
• Length: 90 Millimeter
• Device Size Text, specify: 0
• Width: 90 Millimeter
• Length: 90 Millimeter
• Device Size Text, specify: 0
• Width: 90 Millimeter
• Length: 90 Millimeter
• Device Size Text, specify: 0
• Width: 90 Millimeter
• Length: 90 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	04546540237606 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K983528

FDA Product Code

• JEY: PLATE, BONE

Sterilization

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

[04546540237606]

Moist Heat or Steam Sterilization

[04546540237606]

Moist Heat or Steam Sterilization

[04546540237606]

Moist Heat or Steam Sterilization

[04546540237606]

Moist Heat or Steam Sterilization

[04546540237606]

Moist Heat or Steam Sterilization

[04546540237606]

Moist Heat or Steam Sterilization

[04546540237606]

Moist Heat or Steam Sterilization

[04546540237606]

Moist Heat or Steam Sterilization

[04546540237606]

Moist Heat or Steam Sterilization

[04546540237606]

Moist Heat or Steam Sterilization

[04546540237606]

Moist Heat or Steam Sterilization

[04546540237606]

Moist Heat or Steam Sterilization

[04546540237606]

Moist Heat or Steam Sterilization

[04546540237606]

Moist Heat or Steam Sterilization

[04546540237606]

Moist Heat or Steam Sterilization

[04546540237606]

Moist Heat or Steam Sterilization

[04546540237606]

Moist Heat or Steam Sterilization

[04546540237606]

Moist Heat or Steam Sterilization

[04546540237606]

Moist Heat or Steam Sterilization

[04546540237606]

Moist Heat or Steam Sterilization

[04546540237606]

Moist Heat or Steam Sterilization

[04546540237606]

Moist Heat or Steam Sterilization

[04546540237606]

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: 2015-09-24

On-Brand Devices [UNIVERSAL NEURO 2, UNIVERSAL NEURO III]

• 04546540684875: DYNAMIC MESH STD F. 1.5/1.7MM SCREWS
• 04546540684868: DYNAMIC MESH MALL. F. 1.5/1.7MM SCREWS
• 04546540684431: LID UNIV.NEURO CONTAINER,QUARTER-SIZE
• 04546540684424: UNIVERSAL CONTAINER, QUARTER-SIZE
• 04546540684417: LIFT OUT INLAY COMBINED TRAY
• 04546540684400: SILICONE MAT COMBINED TRAY
• 04546540684394: COMBINED TRAY, UNIVERSAL NEURO
• 04546540684387: LID, COMBINED TRAY
• 04546540543028: DRILL, WL 6MM, STRYKER SHAFT
• 04546540394170: SCREWDRIVER HANDLE, TEAL
• 04546540237668: DYNAMIC MESH STD F. 1.5/1.7MM SCREWS
• 04546540237651: DYNAMIC MESH STD F. 1.5/1.7MM SCREWS
• 04546540237606: DYNAMIC MESH MALL. F. 1.5/1.7MM SCREWS
• 04546540237590: DYNAMIC MESH MALL. F. 1.5/1.7MM SCREWS
• 04546540237569: Micro Mesh
• 04546540237538: Micro Mesh