4740003

GUDID 07613327384796

STERNALPLATE, BOX

Stryker Leibinger GmbH & Co. KG

Sternal fixation device

• Primary Device ID: 07613327384796
• NIH Device Record Key: e8205bed-da5f-448d-a06d-50d115545cf4
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 4740003
• Catalog Number: 4740003
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	07613327384796 [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

[07613327384796]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-04-24
• Device Publish Date: 2019-04-16

Devices Manufactured by Stryker Leibinger GmbH & Co. KG

• 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
• 07613327634952 - NA: 2024-12-16 Drill for 6514-7-200 WL 16mm
• 07613327634969 - NA: 2024-12-16 Drill for 6514-7-200 WL 12mm
• 07613327634976 - NA: 2024-12-16 Drill for 6514-7-200 WL 10mm
• 07613327634983 - NA: 2024-12-16 Drill for 6514-7-200 WL 12mm