Tatum Surgical Bone Fixation Screw Bone Fix Scw 1.75x12mm

GUDID 00083208006197

Bone Fixation Self-Drilling Screw for securing bone blocks

Suncoast Dental, Inc

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

• Primary Device ID: 00083208006197
• NIH Device Record Key: ede6789f-e440-420a-be87-b9b85d381602
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tatum Surgical Bone Fixation Screw
• Version Model Number: Bone Fix Scw 1.75x12mm
• Catalog Number: Bone Fix Scw 1.75x12mm
• Company DUNS: 078352849
• Company Name: Suncoast Dental, Inc
• Device Count: 1
• DM Exempt: true
• 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: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (727) 536-4880
• Email: tatumimplants@verizon.net
• Phone: (727) 536-4880
• Email: tatumimplants@verizon.net

Device Dimensions

• Outer Diameter: 1.75 Millimeter
• Length: 12 Millimeter
• Outer Diameter: 1.75 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00083208006197 [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

[00083208006197]

Moist Heat or Steam Sterilization

[00083208006197]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-01-01
• Device Publish Date: 2019-12-24

On-Brand Devices [Tatum Surgical Bone Fixation Screw]

• 00083208006418: Bone Fixation Self-Drilling Screw for securing bone blocks
• 00083208006241: Bone Fixation Self-Drilling Screw for securing bone blocks
• 00083208006234: Bone Fixation Self-Drilling Screw for securing bone blocks
• 00083208006227: Bone Fixation Self-Drilling Screw for securing bone blocks
• 00083208006210: Bone Fixation Self-Drilling Screw for securing bone blocks
• 00083208006203: Bone Fixation Self-Drilling Screw for securing bone blocks
• 00083208006197: Bone Fixation Self-Drilling Screw for securing bone blocks
• 00083208006180: Bone Fixation Self-Drilling Screw for securing bone blocks
• 00083208006173: Bone Fixation Self-Drilling Screw for securing bone blocks
• 00083208006142: Bone Fixation Self-Drilling Screw for securing bone blocks
• 00083208006135: Bone Fixation Self-Drilling Screw for securing bone blocks