Safety Release Modules

GUDID 00190730007377

Safety Module Steel Hvy 10/pk 750gm

ORTHO TECHNOLOGY, INC.

Orthodontic extraoral headgear

• Primary Device ID: 00190730007377
• NIH Device Record Key: 9f029a6f-f403-49d6-ab19-02baa23cd387
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Safety Release Modules
• Version Model Number: 550-111
• 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	00190730007377 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K980151

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: 2017-11-17

On-Brand Devices [Safety Release Modules]

• 00190730007377: Safety Module Steel Hvy 10/pk 750gm
• 00190730007360: Safety Module Steel Med 10/pk 600gm
• 00190730002891: Safety Module Plastic Hvy 10pk 750gm
• 00190730002884: Safety Module Plastic Med 10pk 600gm