Safety Release Spring Module 852-821

GUDID 00190746008085

SAFETY RELEASE SPRING MODULE - MEDIUM/20 OZ WHITE 10/PKG

AMERICAN ORTHODONTICS CORPORATION

Orthodontic extraoral headgear

• Primary Device ID: 00190746008085
• NIH Device Record Key: 4c5d3cdc-0596-46e9-ada9-8d04e12aff05
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Safety Release Spring Module
• Version Model Number: 852-821
• Catalog Number: 852-821
• Company DUNS: 044668515
• Company Name: AMERICAN ORTHODONTICS CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: 800-558-7687
• Email: info@americanortho.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00190746008085 [Primary]

FDA Product Code

• DZB: Headgear, Extraoral, Orthodontic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-12-07

On-Brand Devices [Safety Release Spring Module]

• 00190746008108: SAFETY RELEASE SPRING MODULE - MEDIUM/20 OZ WHITE/WHITE 10/PKG
• 00190746008092: SAFETY RELEASE SPRING MODULE - HEAVY/23 OZ BLUE 10/PKG
• 00190746008085: SAFETY RELEASE SPRING MODULE - MEDIUM/20 OZ WHITE 10/PKG
• 00190746073649: SAFETY RELEASE SPRING MODULE - LIGHT/16 OZ CLEAR 10/PK