First Molar Single Tubes

GUDID 00192029019511

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

TP ORTHODONTICS INC

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• Primary Device ID: 00192029019511
• NIH Device Record Key: 8fa7e937-4c5a-4cff-9e0f-6b4554e1590e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: First Molar Single Tubes
• Version Model Number: 210-396R
• 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	00192029019511 [Primary]

FDA Product Code

• ECN: CLAMP, WIRE, 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 [First Molar Single Tubes]

• 00192029019535: UR 1st Molar Torque 0, Tip 0, Distal Offset 0
• 00192029019528: UL 1st Molar Torque 0, Tip 0, Distal Offset 0
• 00192029019511: UR 1st Molar Torque 0, Tip 0, Distal Offset 0
• 00192029019504: UL 1st Molar Torque 0, Tip 0, Distal Offset 0