24-20407

GUDID 37613154156109

BONE SCREWS, CROSS-PIN

Stryker Leibinger GmbH & Co. KG

Craniofacial bone screw, non-bioabsorbable, sterile Craniofacial bone screw, non-bioabsorbable, sterile Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable

• Primary Device ID: 37613154156109
• NIH Device Record Key: 92ffee6c-908f-497c-b678-ef34adb9cf5c
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 24-20407
• Catalog Number: 24-20407
• Company DUNS: 316153956
• Company Name: Stryker Leibinger GmbH & Co. KG
• Device Count: 4
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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: true
• 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

• Length: 7 Millimeter
• Device Size Text, specify: 0
• Length: 7 Millimeter
• Device Size Text, specify: 0
• Length: 7 Millimeter
• Device Size Text, specify: 0
• Length: 7 Millimeter
• Device Size Text, specify: 0
• Length: 7 Millimeter
• Device Size Text, specify: 0
• Length: 7 Millimeter
• Device Size Text, specify: 0
• Length: 7 Millimeter
• Device Size Text, specify: 0
• Length: 7 Millimeter
• Device Size Text, specify: 0
• Length: 7 Millimeter
• Device Size Text, specify: 0
• Length: 7 Millimeter
• Device Size Text, specify: 0
• Length: 7 Millimeter
• Device Size Text, specify: 0
• Length: 7 Millimeter
• Device Size Text, specify: 0
• Length: 7 Millimeter
• Device Size Text, specify: 0
• Length: 7 Millimeter
• Device Size Text, specify: 0
• Length: 7 Millimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613154156108 [Unit of Use]
GS1	37613154156109 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K014263

FDA Product Code

• JEY: PLATE, BONE

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-07-07

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