Intrigue

GUDID 00817573021154

INTRG WHISP ROTH CUS 0T+11A 022 UR

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: 00817573021154
• NIH Device Record Key: 8f6ebdc0-193f-42ca-9311-c35c614ecbb5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Intrigue
• Version Model Number: 231-123
• 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	00817573021154 [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: 2016-12-03

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