Ultra Low Profile Single Molar Tube

GUDID 00192029015629

UR/LL 1st Molar Torque -10, Tip 0, Distal Offset 0 0.46 x 0.64mm (.018" x .025") 4.0 mm

TP ORTHODONTICS INC

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• Primary Device ID: 00192029015629
• NIH Device Record Key: 3fb71ebc-81c2-445d-8e02-1dcea5e7f332
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ultra Low Profile Single Molar Tube
• Version Model Number: 391-739
• Company DUNS: 005432299
• Company Name: TP ORTHODONTICS INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00192029015629 [Primary]

FDA Product Code

• DZD: TUBE, ORTHODONTIC

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-03-23
• Device Publish Date: 2021-03-15

On-Brand Devices [Ultra Low Profile Single Molar Tube]

• 00192029025789: LR 2nd Molar Torque -25, Tip 0, Distal Offset 5
• 00192029025772: UR 2nd Molar Torque -14, Tip 0, Distal Offset 10
• 00192029025765: UL 2nd Molar Torque -14, Tip 0, Distal Offset 10
• 00192029025758: UR 2nd Molar Torque -14, Tip 0, Distal Offset 10
• 00192029025741: UL 2nd Molar Torque -14, Tip 0, Distal Offset 10
• 00192029025734: LR 1st Molar Torque -25, Tip 0, Distal Offset 0
• 00192029025727: LL 1st Molar Torque -25, Tip 0, Distal Offset 0
• 00192029025710: LR 1st Molar Torque -25, Tip 0, Distal Offset 0
• 00192029025703: LL 1st Molar Torque -25, Tip 0, Distal Offset 0
• 00192029025697: UR 1st Molar Torque -14, Tip 0, Distal Offset 10
• 00192029025680: UL 1st Molar Torque -14, Tip 0, Distal Offset 10
• 00192029025673: UR 1st Molar Torque -14, Tip 0, Distal Offset 10
• 00192029025666: UL 1st Molar Torque -14, Tip 0, Distal Offset 10
• 00192029025611: UR/LL 1st Molar Torque -10, Tip 0, Distal Offset 0
• 00192029025604: UL/LR 1st Molar Torque -10, Tip 0, Distal Offset 0
• 00192029015629: UR/LL 1st Molar Torque -10, Tip 0, Distal Offset 0
• 00192029013618: LL 2nd Molar Torque -25, Tip 0, Distal Offset 5