TriStar Screws - 10mm (Pack of 5)

GUDID 00855286006181

Pack of 5 Ti-Alloy Screws, Length: 10mm total, 5mm threaded, 5mm unthreaded

Impladent, Ltd.

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: 00855286006181
• NIH Device Record Key: 2d4aff9c-ddd8-4ec9-8441-096977fc09d2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TriStar Screws - 10mm (Pack of 5)
• Version Model Number: TRI-10
• Company DUNS: 199838400
• Company Name: Impladent, Ltd.
• Device Count: 1
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00855286006181 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141764

FDA Product Code

• DZL: Screw, Fixation, Intraosseous

Sterilization

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

[00855286006181]

Moist Heat or Steam Sterilization

[00855286006181]

Moist Heat or Steam Sterilization

[00855286006181]

Moist Heat or Steam Sterilization

[00855286006181]

Moist Heat or Steam Sterilization

[00855286006181]

Moist Heat or Steam Sterilization

[00855286006181]

Moist Heat or Steam Sterilization

[00855286006181]

Moist Heat or Steam Sterilization

[00855286006181]

Moist Heat or Steam Sterilization

[00855286006181]

Moist Heat or Steam Sterilization

[00855286006181]

Moist Heat or Steam Sterilization

[00855286006181]

Moist Heat or Steam Sterilization

[00855286006181]

Moist Heat or Steam Sterilization

[00855286006181]

Moist Heat or Steam Sterilization

[00855286006181]

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: 2015-10-27

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