29-15064

GUDID 37613154572466

SCREWDISC,UN1,SELF-TAPPING,1.5x4mm,80PK

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: 37613154572466
• NIH Device Record Key: 2286cc55-f442-4016-83f9-92bb829bd7cc
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 29-15064
• Catalog Number: 29-15064
• Company DUNS: 316153956
• Company Name: Stryker Leibinger GmbH & Co. KG
• Device Count: 80
• 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: false
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	07613154572465 [Unit of Use]
GS1	37613154572466 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K031659

FDA Product Code

• JEY: PLATE, BONE

Sterilization

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

[37613154572466]

Moist Heat or Steam Sterilization

[37613154572466]

Moist Heat or Steam Sterilization

[37613154572466]

Moist Heat or Steam Sterilization

[37613154572466]

Moist Heat or Steam Sterilization

[37613154572466]

Moist Heat or Steam Sterilization

[37613154572466]

Moist Heat or Steam Sterilization

[37613154572466]

Moist Heat or Steam Sterilization

[37613154572466]

Moist Heat or Steam Sterilization

[37613154572466]

Moist Heat or Steam Sterilization

[37613154572466]

Moist Heat or Steam Sterilization

[37613154572466]

Moist Heat or Steam Sterilization

[37613154572466]

Moist Heat or Steam Sterilization

[37613154572466]

Moist Heat or Steam Sterilization

[37613154572466]

Moist Heat or Steam Sterilization

[37613154572466]

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: 2015-09-24

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• 07613327556827 - NA: 2024-02-23 Facial iD MF 1 mesh kit