Optyc

GUDID 00817573022595

OPTYC ROTH BIC -7T 0A 018 UP

LANCER ORTHODONTICS, INC.

Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal Orthodontic bracket, metal

• Primary Device ID: 00817573022595
• NIH Device Record Key: b68440ec-1c2b-4059-83b9-f65f20e3d53e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Optyc
• Version Model Number: 246-433
• Company DUNS: 045545589
• Company Name: LANCER ORTHODONTICS, INC.
• Device Count: 1
• DM Exempt: false
• 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	00817573022595 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K902075

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: 2016-12-30

On-Brand Devices [Optyc]

• 00817573022762: OPTYC ROTH 2BIC -22T 0A 022 LOW
• 00817573022755: OPTYC ROTH 1BIC -17T 0A 022 LOW
• 00817573022748: OPTYC ROTH CUS HK -11T 5A 022 LL
• 00817573022731: OPTYC ROTH CUS HK -11T 5A 022 LR
• 00817573022724: OPTYC ROTH ANT 0T 0A 022 LOW
• 00817573022717: OPTYC ROTH BIC -7T 0A 022 UP
• 00817573022700: OPTYC ROTH CUS HK 0T +11A 022 UL
• 00817573022694: OPTYC ROTH CUS HK 0T +11A 022 UR
• 00817573022687: OPTYC ROTH LAT +8T +9A 022 UL
• 00817573022670: OPTYC ROTH LAT +8T +9A 022 UR
• 00817573022663: OPTYC ROTH CENT +12T +5A 022 UL
• 00817573022656: OPTYC ROTH CENT +12T +5A 022 UR
• 00817573022649: OPTYC ROTH 2BIC -22T 0A 018 LOW
• 00817573022632: OPTYC ROTH 1BIC -17T 0A 018 LOW
• 00817573022625: OPTYC ROTH CUS HK -11T 5A 018 LL
• 00817573022618: OPTYC ROTH CUS HK -11T 5A 018 LR
• 00817573022601: OPTYC ROTH ANT 0T 0A 018 LOW
• 00817573022595: OPTYC ROTH BIC -7T 0A 018 UP
• 00817573022588: OPTYC ROTH CUS HK 0T +11A 018 UL
• 00817573022571: OPTYC ROTH CUS HK 0T +11A 018 UR
• 00817573022564: OPTYC ROTH LAT +8T +9A 018 UL
• 00817573022557: OPTYC ROTH LAT +8T +9A 018 UR
• 00817573022540: OPTYC ROTH CENT +12T +5A 018 UL
• 00817573022533: OPTYC ROTH CENT +12T +5A 018 UR