9240013

GUDID 07613327590968

STERNALPLATE, HEX, NARROW

Stryker Leibinger GmbH & Co. KG

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

• Primary Device ID: 07613327590968
• NIH Device Record Key: ecd5b896-9178-4e5d-a9b5-d913c5142b6f
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 9240013
• Catalog Number: 9240013
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	07613327590968 [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

[07613327590968]

Moist Heat or Steam Sterilization

[07613327590968]

Moist Heat or Steam Sterilization

[07613327590968]

Moist Heat or Steam Sterilization

[07613327590968]

Moist Heat or Steam Sterilization

[07613327590968]

Moist Heat or Steam Sterilization

[07613327590968]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-06-10
• Device Publish Date: 2022-06-02

Devices Manufactured by Stryker Leibinger GmbH & Co. KG

• 07613327300024 - NA: 2024-04-18
• 07613327556285 - NA: 2024-02-27 Facial iD MF 1 Mesh
• 07613327556308 - NA: 2024-02-23 Facial iD MF 2 meshes
• 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