Intrigue

GUDID 00817573021765

OPTYC MBT CEN +17T +4A 018 UL

LANCER ORTHODONTICS, INC.

Orthodontic bracket, metal

• Primary Device ID: 00817573021765
• NIH Device Record Key: 211cf1fe-29d6-4fef-92aa-6def0928a7b1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Intrigue
• Version Model Number: 231-402
• 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	00817573021765 [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: 2016-12-04

On-Brand Devices [Intrigue]

• 00817573022526: INTRG ROTH SGL MS CUS -11T5A 022 LL
• 00817573022519: INTRG ROTH SGL MS CUS -11T5A 022 LR
• 00817573022502: INTRG ROTH SGL CUS HK -11T5A 022 LL
• 00817573022496: INTRG ROTH SGL CUS HK -11T5A 022 LR
• 00817573022489: INTRG ROTH SGL LO ANT 0T 0A 022
• 00817573022472: INTRG ROTH SGL MS CUS 0T11A 022 UL
• 00817573022465: INTRG ROTH SGL MS CUS 0T11A 022 UR
• 00817573022458: INTRG ROTH SGL CUS HK 0T11A 022 UL
• 00817573022441: INTRG ROTH SGL CUS HK 0T11A 022 UR
• 00817573022434: INTRG ROTH SGL LAT +8T 9A 022 UL
• 00817573022427: INTRG ROTH SGL LAT +8T 9A 022 UR
• 00817573022410: INTRG ROTH SGL CENT +12T 5A 022 UL
• 00817573022403: INTRG ROTH SGL CENT +12T 5A 022 UR
• 00817573022397: INTRG ROTH SGL MS CUS -11T5A 018 LL
• 00817573022380: INTRG ROTH SGL MS CUS -11T5A 018 LR
• 00817573022373: INTRG ROTH SGL CUS HK -11T5A 018 LL
• 00817573022366: INTRG ROTH SGL CUS HK -11T5A 018 LR
• 00817573022359: INTRG ROTH SGL ANT 0T 0A 018 LOW
• 00817573022342: INTRG ROTH SGL MS CUS 0T11A 018 UR
• 00817573022335: INTRG ROTH SGL CUS HK 0T 11A 018 UL
• 00817573022328: INTRG ROTH SGL CUS HK 0T 11A 018 UR
• 00817573022311: INTRG ROTH SGL LAT +8T 9A 018 UL
• 00817573022304: INTRG ROTH SGL LAT +8T 9A 018 UR
• 00817573022298: INTRG ROTH SGL CENT +12T 5A 018 UL
• 00817573022281: INTRG ROTH SGL CENT +12T 5A 018 UR
• 00817573022274: INTRG ROTH 2BIC -22T 0A 022 LOW
• 00817573022267: INTRG ROTH 2BIC HK -22T 0A 022 LOW
• 00817573022250: INTRG ROTH 1BIC -17T 0A 022 LOW
• 00817573022243: INTRG ROTH 1BIC HK -17T 0A 022 LO
• 00817573022236: INTRG ROTH BIC -7T 0A 022 UP
• 00817573022229: INTRG ROTH BIC HK -7T 0A 022 UP
• 00817573022212: INTRG ROTH LAT +8T +9A 022 UL
• 00817573022205: INTRG ROTH LAT +8T +9A 022 UR
• 00817573022199: INTRG ROTH CENT +12T +5A 022 UL
• 00817573022182: INTRG ROTH CENT +12T +5A 022 UR
• 00817573022175: INTRG ROTH 2BIC -22T 0A 018 LOW
• 00817573022168: INTRG ROTH 2BIC HK -22T 0A 018 LOW
• 00817573022151: INTRG RICKETTS BIC 0T 0A 018 UNIV
• 00817573022144: INTRG ROTH 1BIC -17T 0A 018 LOW
• 00817573022137: INTRG ROTH 1BIC HK -17T 0A 018 LOW
• 00817573022120: INTRG ROTH BIC -7T 0A 018 UP
• 00817573022113: INTRG ROTH BIC HK -7T 0A 018 UP
• 00817573022106: INTRG ROTH LAT +8T +9A 018 UL
• 00817573022090: INTRG ROTH LAT +8T +9A 018 UR
• 00817573022083: INTRG ROTH CENT +12T +5A 018 UL
• 00817573022076: INTRG ROTH CENT +12T +5A 018 UR
• 00817573022069: INTG EDG NT ANT 0T 0A 022 LO
• 00817573022052: INTG EDG MT CUS/BI 0T 0A 022 UP/LO
• 00817573022045: INTG EDG MT LAT 0T 0A 022 UP
• 00817573022038: INTG EDG MWT CENT 0T 0A 022 UP