Contour

GUDID 00190707003616

Contour .022 LR3 -11T 7T 0A

ORTHO ORGANIZERS, INC.

Orthodontic bracket, ceramic

• Primary Device ID: 00190707003616
• NIH Device Record Key: a50fda39-7907-44e2-a980-2f7d745fb522
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Contour
• Version Model Number: 303-13-5
• 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	00190707003616 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110335

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: 2016-09-24

On-Brand Devices [Contour]

• 00190707003647: Contour .022 Kit U/L 5x5 HKS
• 00190707003630: Contour .022 Kit U 5x5 Roth
• 00190707003623: Contour .022 Kit U 3x3 Roth
• 00190707003616: Contour .022 LR3 -11T 7T 0A
• 00190707003609: Contour .022 LL3 -11T 7T 0A
• 00190707003593: Contour .022 LL/R 1/2 0T 0A 0O
• 00190707003586: Contour .022 LL/R 1/2 0T 0A 0O
• 00190707003579: Contour .022 UL/R 4/5 -7T 0A 0O
• 00190707003562: Contour .022 UR3 0T 12A 0O
• 00190707003555: Contour .022 UL3 0T 12A 0O
• 00190707003548: Contour .022 UR2 8T 9A 0O
• 00190707003531: Contour .022 UL2 8T 9A 0O
• 00190707003524: Contour .022 UR1 12T 5A 0O
• 00190707003517: Contour .022 UL1 12T 5A 0O
• 00190707003500: Contour .018 Kit L 3x3 Roth
• 00190707003494: Contour .018 Kit U 5x5 Roth
• 00190707003487: Contour .018 Kit U 3x3 Roth
• 00190707003470: Contour .018 LR3 -11T 7T 0A
• 00190707003463: Contour .018 LL3 -11T 7T 0A
• 00190707003456: Contour .018 LL/R 1/2 0T 0A 0O
• 00190707003449: Contour .018 UL/R 4/5 -7T 0A 0 0O
• 00190707003432: Contour .018 UR3 0T 12A 0O
• 00190707003425: Contour .018 UL3 0T 12A 0O
• 00190707003418: Contour .018 UR2 8T 9A 0O
• 00190707003401: Contour .018 UL2 8T 9A 0O
• 00190707003395: Contour .018 UR1 12T 5A 0O
• 00190707003388: Contour .018 UL1 12T 5A 0O