UNIVERSAL NEURO 3 53-34622

GUDID 04546540684820

Gap Plate, large

Stryker Leibinger GmbH & Co. KG

Craniofacial fixation plate, non-bioabsorbable

• Primary Device ID: 04546540684820
• NIH Device Record Key: f8969a02-2b79-42a6-8c54-78a49b7859cc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UNIVERSAL NEURO 3
• Version Model Number: 53-34622
• Catalog Number: 53-34622
• Company DUNS: 316153956
• Company Name: Stryker Leibinger 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: 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

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Device Identifiers

Device Issuing Agency	Device ID
GS1	04546540684820 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112557

FDA Product Code

• GWO: Plate, cranioplasty, preformed, alterable

Sterilization

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

[04546540684820]

Moist Heat or Steam Sterilization

[04546540684820]

Moist Heat or Steam Sterilization

[04546540684820]

Moist Heat or Steam Sterilization

[04546540684820]

Moist Heat or Steam Sterilization

[04546540684820]

Moist Heat or Steam Sterilization

[04546540684820]

Moist Heat or Steam Sterilization

[04546540684820]

Moist Heat or Steam Sterilization

[04546540684820]

Moist Heat or Steam Sterilization

[04546540684820]

Moist Heat or Steam Sterilization

[04546540684820]

Moist Heat or Steam Sterilization

[04546540684820]

Moist Heat or Steam Sterilization

[04546540684820]

Moist Heat or Steam Sterilization

[04546540684820]

Moist Heat or Steam Sterilization

[04546540684820]

Moist Heat or Steam Sterilization

[04546540684820]

Moist Heat or Steam Sterilization

[04546540684820]

Moist Heat or Steam Sterilization

[04546540684820]

Moist Heat or Steam Sterilization

[04546540684820]

Moist Heat or Steam Sterilization

[04546540684820]

Moist Heat or Steam Sterilization

[04546540684820]

Moist Heat or Steam Sterilization

[04546540684820]

Moist Heat or Steam Sterilization

[04546540684820]

Moist Heat or Steam Sterilization

[04546540684820]

Moist Heat or Steam Sterilization

[04546540684820]

Moist Heat or Steam Sterilization

[04546540684820]

Moist Heat or Steam Sterilization

[04546540684820]

Moist Heat or Steam Sterilization

[04546540684820]

Moist Heat or Steam Sterilization

[04546540684820]

Moist Heat or Steam Sterilization

[04546540684820]

Moist Heat or Steam Sterilization

[04546540684820]

Moist Heat or Steam Sterilization

[04546540684820]

Moist Heat or Steam Sterilization

[04546540684820]

Moist Heat or Steam Sterilization

[04546540684820]

Moist Heat or Steam Sterilization

[04546540684820]

Moist Heat or Steam Sterilization

[04546540684820]

Moist Heat or Steam Sterilization

[04546540684820]

Moist Heat or Steam Sterilization

[04546540684820]

Moist Heat or Steam Sterilization

[04546540684820]

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: 2015-06-29

On-Brand Devices [UNIVERSAL NEURO 3]

• 07613327455786: TEMPORAL PLATE, SMALL
• 07613327420036: UN3 BURR HOLE COVER, SEGMENTED
• 07613327420029: UN3 BURR HOLE COVER, SEGMENTED
• 07613327412307: SHUNT PLATE, WITH TAB
• 07613327314083: INSTRUMENT INLAY
• 07613327314076: PLATE INLAY
• 07613327299182: AXS SCREWDRIVER BLADE FOR 1.5MM
• 07613327292008: Gap Plate, small
• 07613327291995: Gap Plate, large
• 07613327291988: Gap Plate, medium
• 07613327123357: UN3 Shunt Plate, with Tab, 20mm
• 07613327090802: AXS SCREWDRIVER BLADE, 1.5MM
• 07613327090772: Screw, AXS, self-tapping
• 07613327090765: Screw, AXS, Emergency
• 07613327090758: Screw, AXS, self-drilling
• 07613327090741: Screw, AXS, self-drilling
• 07613327090734: Screw, AXS, self-drilling
• 07613327090727: Screw, AXS, self-tapping
• 07613327090710: Screw, AXS, self-tapping
• 07613327090703: Screwdisc, Sd, 1.5x5mm AXS, 80Pk
• 07613327090697: Screwdisc, Sd, 1.5x4mm AXS, 80Pk
• 07613327090680: Screwdisc, St, 1.5x5mm AXS, 80Pk
• 07613327090673: Screwdisc, Sd, 1.5x3mm AXS, 80Pk
• 07613327090604: Screwdisc, St, 1.5x4mm AXS, 80Pk
• 07613252660743: Mesh Plate, round, small
• 07613252660729: Mesh Plate, round, large
• 07613252660712: Suboccipital Plate, large
• 07613252633600: SCREW, SELF-DRILLING
• 07613252633587: SCREW, SELF-DRILLING
• 07613252471547: BOX PLATE, SMALL
• 04546540684851: Straight Plate, 12mm Bar
• 04546540684844: Straight Plate
• 04546540684837: X Plate
• 04546540684820: Gap Plate, large
• 04546540684813: Shunt Plate, with Tab, 20mm
• 04546540684806: Shunt Plate, with Tab, 14mm
• 04546540684790: Gap Plate, small
• 04546540684783: Double-Y Plate
• 04546540684776: Burr Hole Cover, with Tab, 24mm
• 04546540684769: Burr Hole Cover, with Tab, 20mm
• 04546540684752: Burr Hole Cover, with Tab, 14mm
• 04546540684745: Burr Hole Cover, with Tab, 10mm
• 04546540684738: Burr Hole Cover, with Tab, 7mm
• 04546540684721: Straight Plate, 6mm Bar
• 04546540684714: Rectangle Plate
• 04546540684707: Box Plate, large
• 04546540684691: Box Plate, large, with Tab
• 04546540684684: Box Plate, small
• 04546540684677: Straight Plate, 16mm Bar
• 04546540684660: Straight Plate, 12mm Bar, with Tab