F.I.T. 82802

GUDID D746828021

F.I.T. - Medium Tack 1.67mm/Pk of 50

RAINTREE ESSIX INC.

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• Primary Device ID: D746828021
• NIH Device Record Key: e33ac22d-f350-471e-934e-6b4e2b0a3ebc
• Commercial Distribution Discontinuation: 2021-02-18
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: F.I.T.
• Version Model Number: 82802
• Catalog Number: 82802
• Company DUNS: 801157132
• Company Name: RAINTREE ESSIX INC.
• Device Count: 50
• 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: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com
• Phone: +1(800)883-8733
• Email: sales@essix.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D746828020 [Unit of Use]
HIBCC	D746828021 [Primary]

FDA Product Code

• NXC: Aligner, sequential

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2021-09-23
• Device Publish Date: 2016-09-24

On-Brand Devices [F.I.T.]

• D746828031: F.I.T. - Long Tack 2.42mm/Pk of 50
• D746828021: F.I.T. - Medium Tack 1.67mm/Pk of 50
• D746828011: F.I.T. - Short Tack .91mm/Pk of 50