Rumor

GUDID 00190707004507

Rumor .022 UL 4/5 -7T 0A 0O

ORTHO ORGANIZERS, INC.

Orthodontic bracket, ceramic

• Primary Device ID: 00190707004507
• NIH Device Record Key: 5b8c4213-b420-4b59-b0ee-2aa37b5bd1c1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rumor
• Version Model Number: 306-2207-5
• 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	00190707004507 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K922499

FDA Product Code

• EJF: BRACKET, METAL, 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 [Rumor]

• 00190707004675: Rumor™ .022 Kit U/L 5x5 MC HKS
• 00190707004668: Rumor™ .022 Kit U/L 5x5 MC HK
• 00190707004651: Rumor™ .022 Kit U/L 5x5 Roth HKS
• 00190707004644: Rumor .022 LL5 HK -17T 0A 0O
• 00190707004637: Rumor .022 LL5 -17T 0A 0O
• 00190707004620: Rumor .022 LR5 HK -17T 0A 0O
• 00190707004613: Rumor .022 LR5 -17T 0A 0O
• 00190707004606: Rumor .022 LL4 HK -12T 0A 0O
• 00190707004590: Rumor .022 LL4 -12T 0A 0O
• 00190707004583: Rumor .022 LR4 HK -12T 0A 0O
• 00190707004576: Rumor .022 LR4 -12T 0A 0O
• 00190707004569: Rumor .022 LL3 HK -6T 3A 0O
• 00190707004552: Rumor .022 LL3 -6T 3A 0O
• 00190707004545: Rumor .022 LR3 HK -6T 3A 0O
• 00190707004538: Rumor .022 LR3 -6T 3A 0O
• 00190707004521: Rumor .022 LL/R 1/2 -6T 0A 0O
• 00190707004514: Rumor .022 UL 4/5 HK -7T 0A 0O
• 00190707004507: Rumor .022 UL 4/5 -7T 0A 0O
• 00190707004491: Rumor .022 UR 4/5 HK -7T 0A 0O
• 00190707004484: Rumor .022 UR 4/5 -7T 0A 0O
• 00190707004477: Rumor .022 UL3 HK -7T 8A 0O
• 00190707004460: Rumor .022 UL3 -7T 8A 0O
• 00190707004453: Rumor .022 UR3 HK -7T 8A 0O
• 00190707004446: Rumor .022 UR3 -7T 8A 0O
• 00190707004439: Rumor .022 UL2 10T 8A 0O
• 00190707004422: Rumor .022 UR2 10T 8A 0O
• 00190707004415: Rumor .022 UL1 17T 4A 0O
• 00190707004408: Rumor .022 UR1 17T 4A 0O
• 00190707004392: Rumor .018 LL5 HK -17T 0A 0O
• 00190707004385: Rumor .018 LL5 -17T 0A 0O
• 00190707004378: Rumor .018 LR5 HK -17T 0A 0O
• 00190707004361: Rumor .018 LR5 -17T 0A 0O
• 00190707004354: Rumor .018 LL4 HK -12T 0A 0O
• 00190707004347: Rumor .018 LL4 -12T 0A 0O
• 00190707004330: Rumor .018 LR4 HK -12T 0A 0O
• 00190707004323: Rumor .018 LR4 -12T 0A 0O
• 00190707004316: Rumor .018 LL3 HK -6T 3A 0O
• 00190707004309: Rumor .018 LL3 -6T 3A 0O
• 00190707004293: Rumor .018 LR3 HK -6T 3A 0O
• 00190707004286: Rumor .018 LR3 -6T 3A 0O
• 00190707004279: Rumor .018 LL/R 1/2 -6T 0A 0O
• 00190707004262: Rumor .018 UL 4/5 HK -7T 0A 0O
• 00190707004255: Rumor .018 UL 4/5 -7T 0A 0O
• 00190707004248: Rumor .018 UR 4/5 HK -7T 0A 0O
• 00190707004231: Rumor .018 UR 4/5 -7T 0A 0O
• 00190707004224: Rumor .018 UL3 HK -7T 8A 0O
• 00190707004217: Rumor .018 UL3 -7T 8A 0O
• 00190707004200: Rumor .018 UR3 HK -7T 8A 0O
• 00190707004194: Rumor .018 UR3 -7T 8A 0O
• 00190707004187: Rumor .018 UL2 10T 8A 0O