Safety Force

GUDID 00190707000462

SAFETY FORCE MODULES MEDIUM BLUE

ORTHO ORGANIZERS, INC.

Orthodontic extraoral headgear

• Primary Device ID: 00190707000462
• NIH Device Record Key: abb0aa6b-00d2-47a3-9ddc-3491ba6e23eb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Safety Force
• Version Model Number: 3804-440
• Company DUNS: 062165188
• Company Name: ORTHO ORGANIZERS, 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00190707000462 [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: 4
• Public Version Date: 2019-03-14
• Device Publish Date: 2016-09-24

On-Brand Devices [Safety Force]

• 00190707000493: SAFETY FORCE MODULES HEAVY BLACK
• 00190707000486: SAFETY FORCE MODULES HEAVY BLUE
• 00190707000479: SAFETY FORCE MODULES MEDIUM BLACK
• 00190707000462: SAFETY FORCE MODULES MEDIUM BLUE