92-40003

GUDID 07613327539806

STERNALPLATE, BOX

Stryker Leibinger GmbH & Co. KG

Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device Sternal fixation device

• Primary Device ID: 07613327539806
• NIH Device Record Key: 0296c071-6130-4d62-91ed-cbc3faa5e5ef
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 92-40003
• Catalog Number: 92-40003
• 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
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• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327539806 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183172

FDA Product Code

• HRS: Plate, fixation, bone

Sterilization

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

[07613327539806]

Moist Heat or Steam Sterilization

[07613327539806]

Moist Heat or Steam Sterilization

[07613327539806]

Moist Heat or Steam Sterilization

[07613327539806]

Moist Heat or Steam Sterilization

[07613327539806]

Moist Heat or Steam Sterilization

[07613327539806]

Moist Heat or Steam Sterilization

[07613327539806]

Moist Heat or Steam Sterilization

[07613327539806]

Moist Heat or Steam Sterilization

[07613327539806]

Moist Heat or Steam Sterilization

[07613327539806]

Moist Heat or Steam Sterilization

[07613327539806]

Moist Heat or Steam Sterilization

[07613327539806]

Moist Heat or Steam Sterilization

[07613327539806]

Moist Heat or Steam Sterilization

[07613327539806]

Moist Heat or Steam Sterilization

[07613327539806]

Moist Heat or Steam Sterilization

[07613327539806]

Moist Heat or Steam Sterilization

[07613327539806]

Moist Heat or Steam Sterilization

[07613327539806]

Moist Heat or Steam Sterilization

[07613327539806]

Moist Heat or Steam Sterilization

[07613327539806]

Moist Heat or Steam Sterilization

[07613327539806]

Moist Heat or Steam Sterilization

[07613327539806]

Moist Heat or Steam Sterilization

[07613327539806]

Moist Heat or Steam Sterilization

[07613327539806]

Moist Heat or Steam Sterilization

[07613327539806]

Moist Heat or Steam Sterilization

[07613327539806]

Moist Heat or Steam Sterilization

[07613327539806]

Moist Heat or Steam Sterilization

[07613327539806]

Moist Heat or Steam Sterilization

[07613327539806]

Moist Heat or Steam Sterilization

[07613327539806]

Moist Heat or Steam Sterilization

[07613327539806]

Moist Heat or Steam Sterilization

[07613327539806]

Moist Heat or Steam Sterilization

[07613327539806]

Moist Heat or Steam Sterilization

[07613327539806]

Moist Heat or Steam Sterilization

[07613327539806]

Moist Heat or Steam Sterilization

[07613327539806]

Moist Heat or Steam Sterilization

[07613327539806]

Moist Heat or Steam Sterilization

[07613327539806]

Moist Heat or Steam Sterilization

[07613327539806]

Moist Heat or Steam Sterilization

[07613327539806]

Moist Heat or Steam Sterilization

[07613327539806]

Moist Heat or Steam Sterilization

[07613327539806]

Moist Heat or Steam Sterilization

[07613327539806]

Moist Heat or Steam Sterilization

[07613327539806]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-12-10
• Device Publish Date: 2020-12-02

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• 07613327556322 - NA: 2024-02-23 Facial iD MF 3 meshes
• 07613327556346 - NA: 2024-02-23 Facial iD MF 4 meshes
• 07613327556377 - NA: 2024-02-23 Facial iD MF 5 meshes
• 07613327556391 - NA: 2024-02-23 Facial iD MF 6 meshes
• 07613327556827 - NA: 2024-02-23 Facial iD MF 1 mesh kit