Universal Neuro III 92-34614

GUDID 07613327177473

UN3 Shunt PLATE, W/TAB, 14MM

Stryker Leibinger GmbH & Co. KG

Craniofacial fixation plate, non-bioabsorbable

• Primary Device ID: 07613327177473
• NIH Device Record Key: 1ddb5efe-569c-42fd-8e0a-2502527556a0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Universal Neuro III
• Version Model Number: 92-34614
• Catalog Number: 92-34614
• 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

• 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	07613327177473 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112557

FDA Product Code

• GXR: COVER, BURR HOLE

Sterilization

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

[07613327177473]

Moist Heat or Steam Sterilization

[07613327177473]

Moist Heat or Steam Sterilization

[07613327177473]

Moist Heat or Steam Sterilization

[07613327177473]

Moist Heat or Steam Sterilization

[07613327177473]

Moist Heat or Steam Sterilization

[07613327177473]

Moist Heat or Steam Sterilization

[07613327177473]

Moist Heat or Steam Sterilization

[07613327177473]

Moist Heat or Steam Sterilization

[07613327177473]

Moist Heat or Steam Sterilization

[07613327177473]

Moist Heat or Steam Sterilization

[07613327177473]

Moist Heat or Steam Sterilization

[07613327177473]

Moist Heat or Steam Sterilization

[07613327177473]

Moist Heat or Steam Sterilization

[07613327177473]

Moist Heat or Steam Sterilization

[07613327177473]

Moist Heat or Steam Sterilization

[07613327177473]

Moist Heat or Steam Sterilization

[07613327177473]

Moist Heat or Steam Sterilization

[07613327177473]

Moist Heat or Steam Sterilization

[07613327177473]

Moist Heat or Steam Sterilization

[07613327177473]

Moist Heat or Steam Sterilization

[07613327177473]

Moist Heat or Steam Sterilization

[07613327177473]

Moist Heat or Steam Sterilization

[07613327177473]

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: 2017-03-09

On-Brand Devices [Universal Neuro III]

• 07613327392876: SUBOCCIPITAL PLATE, T-SHAPE
• 07613327177473: UN3 Shunt PLATE, W/TAB, 14MM
• 07613327090789: AXS SCREWDRIVER BLADE, 1.5MM
• 07613252446194: UN3 IMPLANT MODULE
• 04546540685018: Screwdriver Blade, 1.5/1.7mm Em
• 04546540685001: SCREWDRIVER BLADE, 1.5/1.7MM EM
• 04546540684998: SCREWDRIVER HANDLE
• 04546540684493: IMPLANT MODULE
• 04546540684462: SCREWDISK
• 04546540684448: ACCESSORY TRAY,QUARTER-SIZE CONTAINER