Genesis-C

GUDID 00190707009380

Genesis-C™ .022" LL/R 1/2 -1A/0T 0 Off

ORTHO ORGANIZERS, INC.

Orthodontic bracket, ceramic

• Primary Device ID: 00190707009380
• NIH Device Record Key: a0087dbd-8fe1-4740-b275-72692fadee56
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Genesis-C
• Version Model Number: 2888-235-5
• 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	00190707009380 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112707

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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-24

On-Brand Devices [Genesis-C]

• 00190707009595: Genesis™ .022" LL4/5 Hk -17A/2T 4D Off
• 00190707009588: Genesis™ .022" LR4/5 Hk -17A/2T 4D Off
• 00190707009571: Genesis™ .022" LL3 Hk -11A/5T 2M Off
• 00190707009564: Genesis™ .022" LR3 Hk -11A/5T 2M Off
• 00190707009557: Genesis™ .022" UL4/5 Hk -7A/0T 2D Off
• 00190707009540: Genesis™ .022" UR4/5 Hk -7A/0T 2D Off
• 00190707009533: Genesis™ .022" UL3 Hk -2A/9T 4M Off
• 00190707009526: Genesis™ .022" UR3 Hk -2A/9T 4M Off
• 00190707009519: Genesis™ .022" LL/R 1/2 -1A/0T 0 Off
• 00190707009502: Genesis™ .022" UL2 8A/9T 0 Off
• 00190707009496: Genesis™ .022" UR2 8A/9T 0 Off
• 00190707009489: Genesis™ .022" UL1 12A/5T 0 Off
• 00190707009472: Genesis™ .022" UR1 12A/5T 0 Off
• 00190707009465: Genesis-C™ .022" LL4/5 Hk -17A/2T 4D Off
• 00190707009458: Genesis-C™ .022" LR4/5 Hk -17A/2T 4D Off
• 00190707009441: Genesis-C™ .022" LL3 Hk -11A/5T 2M Off
• 00190707009434: Genesis-C™ .022" LR3 Hk -11A/5T 2M Off
• 00190707009427: Genesis-C™ .022" UL4/5 Hk -7A/0T 2D Off
• 00190707009410: Genesis-C™ .022" UR4/5 Hk -7A/0T 2D Off
• 00190707009403: Genesis-C™ .022" UL3 Hk -2A/9T 4M Off
• 00190707009397: Genesis-C™ .022" UR3 Hk -2A/9T 4M Off
• 00190707009380: Genesis-C™ .022" LL/R 1/2 -1A/0T 0 Off
• 00190707009373: Genesis-C™ .022" UL2 8A/9T 0 Off
• 00190707009366: Genesis-C™ .022" UR2 8A/9T 0 Off
• 00190707009359: Genesis-C™ .022" UL1 12A/5T 0 Off
• 00190707009342: Genesis-C™ .022" UR1 12A/5T 0 Off
• 00190707000448: Genesis-C 022 Roth Kit 5x5