High Pull Head Caps

GUDID 00190730007322

High Pull Royal Blue 5/pk One Size Fits All

ORTHO TECHNOLOGY, INC.

Orthodontic extraoral headgear

• Primary Device ID: 00190730007322
• NIH Device Record Key: 0edcc87e-6d7a-439b-8874-1f502427330b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: High Pull Head Caps
• Version Model Number: 550-750
• Company DUNS: 781772017
• Company Name: ORTHO TECHNOLOGY, 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: 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	00190730007322 [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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-11-01

On-Brand Devices [High Pull Head Caps]

• 00190730007322: High Pull Royal Blue 5/pk One Size Fits All
• 00190730007315: High Pull Assorted Royal Blue, Black, Denim, Crimson, Surf 5/pk One Size Fits All