52-20358

GUDID 34546540227608

BONE SCREWS, CROSS-FIT, SELF-TAPPING

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: 34546540227608
• NIH Device Record Key: 7c93fab2-1f1e-40fb-ba6f-6f81ad9ad001
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 52-20358
• Catalog Number: 52-20358
• 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: 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
• Length: 8 Millimeter
• Device Size Text, specify: 0
• Length: 8 Millimeter
• Device Size Text, specify: 0
• Length: 8 Millimeter
• Device Size Text, specify: 0
• Length: 8 Millimeter
• Device Size Text, specify: 0
• Length: 8 Millimeter
• Device Size Text, specify: 0
• Length: 8 Millimeter
• Device Size Text, specify: 0
• Length: 8 Millimeter
• Device Size Text, specify: 0
• Length: 8 Millimeter
• Device Size Text, specify: 0
• Length: 8 Millimeter
• Device Size Text, specify: 0
• Length: 8 Millimeter
• Device Size Text, specify: 0
• Length: 8 Millimeter
• Device Size Text, specify: 0
• Length: 8 Millimeter
• Device Size Text, specify: 0
• Length: 8 Millimeter
• Device Size Text, specify: 0
• Length: 8 Millimeter
• Device Size Text, specify: 0
• Length: 8 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	04546540227607 [Unit of Use]
GS1	34546540227608 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K963030

FDA Product Code

• DZE: IMPLANT, ENDOSSEOUS, ROOT-FORM

Sterilization

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

[34546540227608]

Moist Heat or Steam Sterilization

[34546540227608]

Moist Heat or Steam Sterilization

[34546540227608]

Moist Heat or Steam Sterilization

[34546540227608]

Moist Heat or Steam Sterilization

[34546540227608]

Moist Heat or Steam Sterilization

[34546540227608]

Moist Heat or Steam Sterilization

[34546540227608]

Moist Heat or Steam Sterilization

[34546540227608]

Moist Heat or Steam Sterilization

[34546540227608]

Moist Heat or Steam Sterilization

[34546540227608]

Moist Heat or Steam Sterilization

[34546540227608]

Moist Heat or Steam Sterilization

[34546540227608]

Moist Heat or Steam Sterilization

[34546540227608]

Moist Heat or Steam Sterilization

[34546540227608]

Moist Heat or Steam Sterilization

[34546540227608]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-06-16

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