Tatum Surgical ITI Integrity Ball Screw PITI 2.5 Ball Screw

GUDID 00083208925016

Integrity 2.5mm ball screw

Suncoast Dental, Inc

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• Primary Device ID: 00083208925016
• NIH Device Record Key: 1fce399f-66b0-4d5e-9432-073b73170281
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tatum Surgical ITI Integrity Ball Screw
• Version Model Number: PITI 2.5 Ball Screw
• Catalog Number: PITI 2.5 Ball Screw
• 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: 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

Customer Support Contacts

• Phone: +1(727)536-4880
• Email: tatumimplants@verizon.net
• Phone: +1(727)536-4880
• Email: tatumcompliance@gmail.com
• Phone: +1(727)536-4880
• Email: tatumcompliance@gmail.com
• Phone: +1(727)536-4880
• Email: tatumcompliance@gmail.com
• Phone: +1(727)536-4880
• Email: tatumcompliance@gmail.com
• Phone: +1(727)536-4880
• Email: tatumcompliance@gmail.com
• Phone: +1(727)536-4880
• Email: tatumcompliance@gmail.com
• Phone: +1(727)536-4880
• Email: tatumcompliance@gmail.com
• Phone: +1(727)536-4880
• Email: tatumcompliance@gmail.com
• Phone: +1(727)536-4880
• Email: tatumcompliance@gmail.com
• Phone: +1(727)536-4880
• Email: tatumcompliance@gmail.com
• Phone: +1(727)536-4880
• Email: tatumcompliance@gmail.com
• Phone: +1(727)536-4880
• Email: tatumcompliance@gmail.com
• Phone: +1(727)536-4880
• Email: tatumcompliance@gmail.com
• Phone: +1(727)536-4880
• Email: tatumcompliance@gmail.com
• Phone: +1(727)536-4880
• Email: tatumcompliance@gmail.com
• Phone: +1(727)536-4880
• Email: tatumcompliance@gmail.com
• Phone: +1(727)536-4880
• Email: tatumcompliance@gmail.com
• Phone: +1(727)536-4880
• Email: tatumcompliance@gmail.com
• Phone: +1(727)536-4880
• Email: tatumcompliance@gmail.com
• Phone: +1(727)536-4880
• Email: tatumcompliance@gmail.com
• Phone: +1(727)536-4880
• Email: tatumcompliance@gmail.com
• Phone: +1(727)536-4880
• Email: tatumcompliance@gmail.com
• Phone: +1(727)536-4880
• Email: tatumcompliance@gmail.com
• Phone: +1(727)536-4880
• Email: tatumcompliance@gmail.com
• Phone: +1(727)536-4880
• Email: tatumcompliance@gmail.com
• Phone: +1(727)536-4880
• Email: tatumcompliance@gmail.com
• Phone: +1(727)536-4880
• Email: tatumcompliance@gmail.com
• Phone: +1(727)536-4880
• Email: tatumcompliance@gmail.com
• Phone: +1(727)536-4880
• Email: tatumcompliance@gmail.com
• Phone: +1(727)536-4880
• Email: tatumcompliance@gmail.com
• Phone: +1(727)536-4880
• Email: tatumcompliance@gmail.com
• Phone: +1(727)536-4880
• Email: tatumcompliance@gmail.com
• Phone: +1(727)536-4880
• Email: tatumcompliance@gmail.com
• Phone: +1(727)536-4880
• Email: tatumcompliance@gmail.com
• Phone: +1(727)536-4880
• Email: tatumcompliance@gmail.com
• Phone: +1(727)536-4880
• Email: tatumcompliance@gmail.com
• Phone: +1(727)536-4880
• Email: tatumcompliance@gmail.com
• Phone: +1(727)536-4880
• Email: tatumcompliance@gmail.com
• Phone: +1(727)536-4880
• Email: tatumcompliance@gmail.com
• Phone: +1(727)536-4880
• Email: tatumcompliance@gmail.com
• Phone: +1(727)536-4880
• Email: tatumcompliance@gmail.com
• Phone: +1(727)536-4880
• Email: tatumcompliance@gmail.com
• Phone: +1(727)536-4880
• Email: tatumcompliance@gmail.com
• Phone: +1(727)536-4880
• Email: tatumcompliance@gmail.com
• Phone: +1(727)536-4880
• Email: tatumcompliance@gmail.com
• Phone: +1(727)536-4880
• Email: tatumcompliance@gmail.com
• Phone: +1(727)536-4880
• Email: tatumcompliance@gmail.com
• Phone: +1(727)536-4880
• Email: tatumcompliance@gmail.com
• Phone: +1(727)536-4880
• Email: tatumcompliance@gmail.com
• Phone: +1(727)536-4880
• Email: tatumcompliance@gmail.com
• Phone: +1(727)536-4880
• Email: tatumcompliance@gmail.com
• Phone: +1(727)536-4880
• Email: tatumcompliance@gmail.com
• Phone: +1(727)536-4880
• Email: tatumcompliance@gmail.com
• Phone: +1(727)536-4880
• Email: tatumcompliance@gmail.com
• Phone: +1(727)536-4880
• Email: tatumcompliance@gmail.com
• Phone: +1(727)536-4880
• Email: tatumcompliance@gmail.com
• Phone: +1(727)536-4880
• Email: tatumcompliance@gmail.com
• Phone: +1(727)536-4880
• Email: tatumcompliance@gmail.com
• Phone: +1(727)536-4880
• Email: tatumcompliance@gmail.com
• Phone: +1(727)536-4880
• Email: tatumcompliance@gmail.com
• Phone: +1(727)536-4880
• Email: tatumcompliance@gmail.com
• Phone: +1(727)536-4880
• Email: tatumcompliance@gmail.com
• Phone: +1(727)536-4880
• Email: tatumcompliance@gmail.com
• Phone: +1(727)536-4880
• Email: tatumcompliance@gmail.com

Device Dimensions

• Outer Diameter: 2.5 Millimeter
• Outer Diameter: 2.5 Millimeter
• Outer Diameter: 2.5 Millimeter
• Outer Diameter: 2.5 Millimeter
• Outer Diameter: 2.5 Millimeter
• Outer Diameter: 2.5 Millimeter
• Outer Diameter: 2.5 Millimeter
• Outer Diameter: 2.5 Millimeter
• Outer Diameter: 2.5 Millimeter
• Outer Diameter: 2.5 Millimeter
• Outer Diameter: 2.5 Millimeter
• Outer Diameter: 2.5 Millimeter
• Outer Diameter: 2.5 Millimeter
• Outer Diameter: 2.5 Millimeter
• Outer Diameter: 2.5 Millimeter
• Outer Diameter: 2.5 Millimeter
• Outer Diameter: 2.5 Millimeter
• Outer Diameter: 2.5 Millimeter
• Outer Diameter: 2.5 Millimeter
• Outer Diameter: 2.5 Millimeter
• Outer Diameter: 2.5 Millimeter
• Outer Diameter: 2.5 Millimeter
• Outer Diameter: 2.5 Millimeter
• Outer Diameter: 2.5 Millimeter
• Outer Diameter: 2.5 Millimeter
• Outer Diameter: 2.5 Millimeter
• Outer Diameter: 2.5 Millimeter
• Outer Diameter: 2.5 Millimeter
• Outer Diameter: 2.5 Millimeter
• Outer Diameter: 2.5 Millimeter
• Outer Diameter: 2.5 Millimeter
• Outer Diameter: 2.5 Millimeter
• Outer Diameter: 2.5 Millimeter
• Outer Diameter: 2.5 Millimeter
• Outer Diameter: 2.5 Millimeter
• Outer Diameter: 2.5 Millimeter
• Outer Diameter: 2.5 Millimeter
• Outer Diameter: 2.5 Millimeter
• Outer Diameter: 2.5 Millimeter
• Outer Diameter: 2.5 Millimeter
• Outer Diameter: 2.5 Millimeter
• Outer Diameter: 2.5 Millimeter
• Outer Diameter: 2.5 Millimeter
• Outer Diameter: 2.5 Millimeter
• Outer Diameter: 2.5 Millimeter
• Outer Diameter: 2.5 Millimeter
• Outer Diameter: 2.5 Millimeter
• Outer Diameter: 2.5 Millimeter
• Outer Diameter: 2.5 Millimeter
• Outer Diameter: 2.5 Millimeter
• Outer Diameter: 2.5 Millimeter
• Outer Diameter: 2.5 Millimeter
• Outer Diameter: 2.5 Millimeter
• Outer Diameter: 2.5 Millimeter
• Outer Diameter: 2.5 Millimeter
• Outer Diameter: 2.5 Millimeter
• Outer Diameter: 2.5 Millimeter
• Outer Diameter: 2.5 Millimeter
• Outer Diameter: 2.5 Millimeter
• Outer Diameter: 2.5 Millimeter
• Outer Diameter: 2.5 Millimeter
• Outer Diameter: 2.5 Millimeter
• Outer Diameter: 2.5 Millimeter
• Outer Diameter: 2.5 Millimeter
• Outer Diameter: 2.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00083208925016 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K811923

FDA Product Code

• DZE: IMPLANT, ENDOSSEOUS, ROOT-FORM
• NDP: Accessories, Implant, Dental, Endosseous
• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[00083208925016]

Moist Heat or Steam Sterilization

[00083208925016]

Moist Heat or Steam Sterilization

[00083208925016]

Moist Heat or Steam Sterilization

[00083208925016]

Moist Heat or Steam Sterilization

[00083208925016]

Moist Heat or Steam Sterilization

[00083208925016]

Moist Heat or Steam Sterilization

[00083208925016]

Moist Heat or Steam Sterilization

[00083208925016]

Moist Heat or Steam Sterilization

[00083208925016]

Moist Heat or Steam Sterilization

[00083208925016]

Moist Heat or Steam Sterilization

[00083208925016]

Moist Heat or Steam Sterilization

[00083208925016]

Moist Heat or Steam Sterilization

[00083208925016]

Moist Heat or Steam Sterilization

[00083208925016]

Moist Heat or Steam Sterilization

[00083208925016]

Moist Heat or Steam Sterilization

[00083208925016]

Moist Heat or Steam Sterilization

[00083208925016]

Moist Heat or Steam Sterilization

[00083208925016]

Moist Heat or Steam Sterilization

[00083208925016]

Moist Heat or Steam Sterilization

[00083208925016]

Moist Heat or Steam Sterilization

[00083208925016]

Moist Heat or Steam Sterilization

[00083208925016]

Moist Heat or Steam Sterilization

[00083208925016]

Moist Heat or Steam Sterilization

[00083208925016]

Moist Heat or Steam Sterilization

[00083208925016]

Moist Heat or Steam Sterilization

[00083208925016]

Moist Heat or Steam Sterilization

[00083208925016]

Moist Heat or Steam Sterilization

[00083208925016]

Moist Heat or Steam Sterilization

[00083208925016]

Moist Heat or Steam Sterilization

[00083208925016]

Moist Heat or Steam Sterilization

[00083208925016]

Moist Heat or Steam Sterilization

[00083208925016]

Moist Heat or Steam Sterilization

[00083208925016]

Moist Heat or Steam Sterilization

[00083208925016]

Moist Heat or Steam Sterilization

[00083208925016]

Moist Heat or Steam Sterilization

[00083208925016]

Moist Heat or Steam Sterilization

[00083208925016]

Moist Heat or Steam Sterilization

[00083208925016]

Moist Heat or Steam Sterilization

[00083208925016]

Moist Heat or Steam Sterilization

[00083208925016]

Moist Heat or Steam Sterilization

[00083208925016]

Moist Heat or Steam Sterilization

[00083208925016]

Moist Heat or Steam Sterilization

[00083208925016]

Moist Heat or Steam Sterilization

[00083208925016]

Moist Heat or Steam Sterilization

[00083208925016]

Moist Heat or Steam Sterilization

[00083208925016]

Moist Heat or Steam Sterilization

[00083208925016]

Moist Heat or Steam Sterilization

[00083208925016]

Moist Heat or Steam Sterilization

[00083208925016]

Moist Heat or Steam Sterilization

[00083208925016]

Moist Heat or Steam Sterilization

[00083208925016]

Moist Heat or Steam Sterilization

[00083208925016]

Moist Heat or Steam Sterilization

[00083208925016]

Moist Heat or Steam Sterilization

[00083208925016]

Moist Heat or Steam Sterilization

[00083208925016]

Moist Heat or Steam Sterilization

[00083208925016]

Moist Heat or Steam Sterilization

[00083208925016]

Moist Heat or Steam Sterilization

[00083208925016]

Moist Heat or Steam Sterilization

[00083208925016]

Moist Heat or Steam Sterilization

[00083208925016]

Moist Heat or Steam Sterilization

[00083208925016]

Moist Heat or Steam Sterilization

[00083208925016]

Moist Heat or Steam Sterilization

[00083208925016]

Moist Heat or Steam Sterilization

[00083208925016]

Moist Heat or Steam Sterilization

[00083208925016]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-02-07
• Device Publish Date: 2020-01-30

On-Brand Devices [Tatum Surgical ITI Integrity Ball Screw]

• 00083208925016: Integrity 2.5mm ball screw
• 00083208920011: Integrity 2.0mm ball screw