Rounded Rectangular Wire

GUDID 00192029029589

Standard Arch Form Lower

TP ORTHODONTICS INC

Orthodontic wire Orthodontic wire Orthodontic wire Orthodontic wire Orthodontic wire Orthodontic wire Orthodontic wire Orthodontic wire Orthodontic wire Orthodontic wire Orthodontic wire Orthodontic wire Orthodontic wire Orthodontic wire

• Primary Device ID: 00192029029589
• NIH Device Record Key: 425106fc-1133-4de2-ae74-8d8edb32f740
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rounded Rectangular Wire
• Version Model Number: 381-396
• 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	00192029029589 [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: 2021-03-23
• Device Publish Date: 2021-03-15

On-Brand Devices [Rounded Rectangular Wire]

• 00192029029596: Standard Arch Form Upper
• 00192029029589: Standard Arch Form Lower
• 00192029016213: 0.48 x 0.66mm (.019" x .026")
• 00192029016206: 0.46 x 0.64mm (.018" x .025")