Genesis-C

GUDID 00190707009427

Genesis-C™ .022" UL4/5 Hk -7A/0T 2D Off

ORTHO ORGANIZERS, INC.

Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic Orthodontic bracket, ceramic

• Primary Device ID: 00190707009427
• NIH Device Record Key: 1d386aec-d77c-4d7a-8b7d-8db0447c9a70
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Genesis-C
• Version Model Number: 2888-260-5
• 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	00190707009427 [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