Signature III bracket

GUDID 00885797004260

Orthodontic ceramic bracket

RMO, INC.

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• Primary Device ID: 00885797004260
• NIH Device Record Key: ad6fce6e-aa6c-4658-9c0f-80a75734e6ea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Signature III bracket
• Version Model Number: 0Q03011
• Company DUNS: 007058183
• Company Name: RMO, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• 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	00885797004260 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120471

FDA Product Code

• NJM: Bracket, Ceramic, 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: 2017-02-09