Rounded Rectangualr Wire

GUDID 00192029035054

Bio-Arch III Rectangular

TP ORTHODONTICS INC

Orthodontic wire

• Primary Device ID: 00192029035054
• NIH Device Record Key: 6b763db5-c6b4-421d-a63c-8403b84cbb99
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rounded Rectangualr Wire
• Version Model Number: 381-450
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)348-8856
• Email: nicholas.smith@tportho.com
• Phone: +1(800)348-8856
• Email: nicholas.smith@tportho.com
• Phone: +1(800)348-8856
• Email: nicholas.smith@tportho.com
• Phone: +1(800)348-8856
• Email: nicholas.smith@tportho.com
• Phone: +1(800)348-8856
• Email: nicholas.smith@tportho.com
• Phone: +1(800)348-8856
• Email: nicholas.smith@tportho.com
• Phone: +1(800)348-8856
• Email: nicholas.smith@tportho.com
• Phone: +1(800)348-8856
• Email: nicholas.smith@tportho.com
• Phone: +1(800)348-8856
• Email: nicholas.smith@tportho.com
• Phone: +1(800)348-8856
• Email: nicholas.smith@tportho.com
• Phone: +1(800)348-8856
• Email: nicholas.smith@tportho.com
• Phone: +1(800)348-8856
• Email: nicholas.smith@tportho.com
• Phone: +1(800)348-8856
• Email: nicholas.smith@tportho.com
• Phone: +1(800)348-8856
• Email: nicholas.smith@tportho.com
• Phone: +1(800)348-8856
• Email: nicholas.smith@tportho.com
• Phone: +1(800)348-8856
• Email: nicholas.smith@tportho.com
• Phone: +1(800)348-8856
• Email: nicholas.smith@tportho.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00192029035054 [Primary]

FDA Product Code

• DZC: 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: 2024-11-21
• Device Publish Date: 2024-11-13

On-Brand Devices [Rounded Rectangualr Wire]

• 00192029035061: Bio-Arch III Rectangular
• 00192029035054: Bio-Arch III Rectangular