ORTHOQUEST

GUDID 10817713022246

Cervical Neck Pad Star

ORTHOQUEST, INC.

Orthodontic extraoral headgear

• Primary Device ID: 10817713022246
• NIH Device Record Key: d68af6f4-77c2-4e9d-a7fe-42b276b03a5b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ORTHOQUEST
• Version Model Number: L0109
• Company DUNS: 192699952
• Company Name: ORTHOQUEST, INC.
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10817713022246 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K940410

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: 2019-10-29
• Device Publish Date: 2018-08-17

On-Brand Devices [ORTHOQUEST]

• 10817713022628: Coated Facebow Black
• 10817713022253: Neckpads - Assorted Colors
• 10817713022246: Cervical Neck Pad Star
• 10817713022451: Rel Modules 600g Red
• 10817713022345: Pull Head Cap Red Large