UNIVERSAL NEURO 2 53-05406

GUDID 04546540394033

LOW PROFILE PLATE

Stryker Leibinger GmbH & Co. KG

Craniofacial fixation plate, non-bioabsorbable

• Primary Device ID: 04546540394033
• NIH Device Record Key: 5a946cac-92fa-46ed-bc5d-e48d35eef62b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UNIVERSAL NEURO 2
• Version Model Number: 53-05406
• Catalog Number: 53-05406
• 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	04546540394033 [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

[04546540394033]

Moist Heat or Steam Sterilization

[04546540394033]

Moist Heat or Steam Sterilization

[04546540394033]

Moist Heat or Steam Sterilization

[04546540394033]

Moist Heat or Steam Sterilization

[04546540394033]

Moist Heat or Steam Sterilization

[04546540394033]

Moist Heat or Steam Sterilization

[04546540394033]

Moist Heat or Steam Sterilization

[04546540394033]

Moist Heat or Steam Sterilization

[04546540394033]

Moist Heat or Steam Sterilization

[04546540394033]

Moist Heat or Steam Sterilization

[04546540394033]

Moist Heat or Steam Sterilization

[04546540394033]

Moist Heat or Steam Sterilization

[04546540394033]

Moist Heat or Steam Sterilization

[04546540394033]

Moist Heat or Steam Sterilization

[04546540394033]

Moist Heat or Steam Sterilization

[04546540394033]

Moist Heat or Steam Sterilization

[04546540394033]

Moist Heat or Steam Sterilization

[04546540394033]

Moist Heat or Steam Sterilization

[04546540394033]

Moist Heat or Steam Sterilization

[04546540394033]

Moist Heat or Steam Sterilization

[04546540394033]

Moist Heat or Steam Sterilization

[04546540394033]

Moist Heat or Steam Sterilization

[04546540394033]

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]

• 07613252305194: UNIVERSAL NEURO 1/4 INSTRUMENT TRAY
• 07613252202417: LOW PROFILE PLATE, CURVED, BAR 6MM
• 07613252202400: LOW PROFILE PLATE, CURVED
• 07613154750580: LOW PROFILE PLATE, STRAIGHT
• 07613154750573: LOW PROFILE DOUBLE-Y-PLATE, WITH BAR
• 07613154750566: LOW PROFILE PLATE, WITH TAB
• 07613154750559: LOW PROFILE BHC PLATE,W/TAB, 14mm
• 07613154750542: LOW PROFILE BHC PLATE,W/TAB, 10mm
• 07613154681846: SCREWDRIVER BLADE, 1.5/1.7MM EMERG.
• 07613154681822: LOW PROFILE Y-PLATE
• 07613154681815: LOW PROFILE DOUBLE-Y-PLATE
• 07613154681808: LOW PROFILE T-PLATE
• 07613154681792: LOW PROFILE 3-D BOX PLATE
• 07613154681785: LOW PROFILE PLATE, STRAIGHT
• 07613154674848: LOW PROFILE X-PLATE
• 07613154674831: LOW PROFILE 3-D BOX PLATE,LARGE
• 07613154674824: LOW PROFILE 3-D BOX PLATE WITH TAB
• 07613154629626: LOW PROFILE GAP PLATE, LARGE
• 07613154629619: LOW PROFILE GAP PLATE, SMALL
• 07613154629596: BURR HOLE COVER PL. W.OPENING W/TAB,20mm
• 07613154623921: NEURO SCREW,CROSS-PIN,SELF-TAPPING
• 07613154623914: NEURO SCREW,CROSS-PIN,SELF-TAPPING
• 07613154623907: NEURO SCREW,CROSS-PIN,SELF-TAPPING
• 07613154598922: BURR HOLE COVER PLATE WITH TAB, 30mm
• 07613154598915: BURR HOLE COVER PLATE WITH TAB, 14mm
• 07613154598861: LOW PROFILE 3-D BOX PLATE, WITH TAB
• 07613154572175: LOW PROFILE BURR HOLE COVER PLATE, 18mm
• 07613154557738: EMPTY SCREW DISC,1.5X5MM,SELF-TAPPING
• 07613154557721: EMPTY SCREW DISC,1.5X4MM,SELF-TAPPING
• 07613154546664: PLATE, BAR 6MM, WITH TAB
• 07613154546572: LOW PROFILE PLATE,WITH BAR, 8MM
• 07613154546169: LOW PROFILE 3-D BOX PLATE, LARGE
• 07613154546152: LOW PROFILE X-PLATE
• 07613154482009: LOW PROFILE BURR HOLE COVER, W/TAB, 24mm
• 07613154201877: LOW PROFILE X-PLATE
• 07613154099221: LOW PROFILE 3-D BOX PLATE 2X2 HOLES
• 07613154029990: LOW PROFILE BURR HOLE COVER, W/TAB, 14mm
• 07613154029983: LOW PROFILE BURR HOLE COVER, W/TAB, 20mm
• 07613154014941: LOW PROFILE BURR HOLE COVER, W/TAB, 10mm
• 04546540580146: INLAY UNIVERSAL NEURO MODULE
• 04546540580139: INLAY UNIVERSAL NEURO MODULE
• 04546540580122: UNIVERSAL NEURO MODULE
• 04546540580115: LID UNIV. NEURO CONTAINER, HALF-SIZE
• 04546540580108: UNIV. NEURO CONTAINER,HALF-SIZE
• 04546540518668: Screwdriver Blade, 1.5/1.7mm, short
• 04546540507020: EMPTY SCREW DISC,1.5X5MM,SELF-DRILLING
• 04546540507013: EMPTY SCREW DISC,1.5X4MM,SELF-DRILLING
• 04546540505682: SCREWDRIVER BLADE, 1.5/1.7MM EMERG.
• 04546540505651: LID UNIVERSAL NEURO INSTRUMENT TRAY
• 04546540505644: UNIVERSAL NEURO INSTRUMENT TRAY