78-80010

GUDID 07613327300048

PEEK Customized PRIORITY-PLUS-S

Stryker Leibinger GmbH & Co. KG

Cranioplasty plate, non-alterable

• Primary Device ID: 07613327300048
• NIH Device Record Key: dd593409-295b-439e-8596-f5fe6a69b2ae
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 78-80010
• Catalog Number: 78-80010
• Company DUNS: 316153956
• Company Name: Stryker Leibinger GmbH & Co. KG
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	07613327300048 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152076
• Premarket Notification: K153248

FDA Product Code

• GWO: Plate, cranioplasty, preformed, alterable

Sterilization

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

[07613327300048]

Moist Heat or Steam Sterilization

[07613327300048]

Moist Heat or Steam Sterilization

[07613327300048]

Moist Heat or Steam Sterilization

[07613327300048]

Moist Heat or Steam Sterilization

[07613327300048]

Moist Heat or Steam Sterilization

[07613327300048]

Moist Heat or Steam Sterilization

[07613327300048]

Moist Heat or Steam Sterilization

[07613327300048]

Moist Heat or Steam Sterilization

[07613327300048]

Moist Heat or Steam Sterilization

[07613327300048]

Moist Heat or Steam Sterilization

[07613327300048]

Moist Heat or Steam Sterilization

[07613327300048]

Moist Heat or Steam Sterilization

[07613327300048]

Moist Heat or Steam Sterilization

[07613327300048]

Moist Heat or Steam Sterilization

[07613327300048]

Moist Heat or Steam Sterilization

[07613327300048]

Moist Heat or Steam Sterilization

[07613327300048]

Moist Heat or Steam Sterilization

[07613327300048]

Moist Heat or Steam Sterilization

[07613327300048]

Moist Heat or Steam Sterilization

[07613327300048]

Moist Heat or Steam Sterilization

[07613327300048]

Moist Heat or Steam Sterilization

[07613327300048]

Moist Heat or Steam Sterilization

[07613327300048]

Moist Heat or Steam Sterilization

[07613327300048]

Moist Heat or Steam Sterilization

[07613327300048]

Moist Heat or Steam Sterilization

[07613327300048]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-02-04
• Device Publish Date: 2021-01-27

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• 07613252196259 - FLUOROMAP: 2025-02-05 FLUOROMAP 1.0 - SALES DEMO CD
• 07613252286578 - FLUOROMAP: 2025-02-05 FLUOROMAP 1.0 SOFTWARE
• 07613252286622 - FLUOROMAP: 2025-02-05 FLUOROMAP 1.0 - ENABLE
• 07613327401523 - NA: 2025-01-17 SternalPlate, Transverse, w/ bars
• 07613327401554 - NA: 2025-01-17 SternalPlate, T
• 07613327401561 - NA: 2025-01-17 SternalPlate, Transverse, w/ bars
• 07613327401738 - NA: 2025-01-17 SternalPlate, T