RX1 Metal Bracket Patient Kit

GUDID 00192029010501

UP/LO 5-5 W JIGS 0.56 mm (0.022")

TP ORTHODONTICS INC

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• Primary Device ID: 00192029010501
• NIH Device Record Key: c29cde87-c66a-4caa-a946-d49f8427bbcd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RX1 Metal Bracket Patient Kit
• Version Model Number: 296-002
• 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	00192029010501 [Primary]

FDA Product Code

• EJF: BRACKET, METAL, 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: 2021-02-23
• Device Publish Date: 2021-02-15

On-Brand Devices [RX1 Metal Bracket Patient Kit]

• 00192029017487: RX1 Patient Kit
• 00192029010501: UP/LO 5-5 W JIGS