RX1 Metal Bracket

GUDID 00192029010709

LR ANT W JIGS 3.5 mm Torque -1, Tip +2 0.56 mm (0.022")

TP ORTHODONTICS INC

Orthodontic bracket, metal

• Primary Device ID: 00192029010709
• NIH Device Record Key: e3a1a954-23a1-4fdf-b2aa-ae26e21bfb85
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RX1 Metal Bracket
• Version Model Number: 296-034
• 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	00192029010709 [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]

• 00192029017470: UR CUS W JIGS 5.0 mm Torque -4, Tip +11
• 00192029017463: UL CUS W JIGS 5.0 mm Torque -4, Tip +11
• 00192029011461: LR CUS W JIGS 4.5 mm Torque -11, Tip +5
• 00192029011454: LL CUS W JIGS 4.5 mm Torque -11, Tip +5
• 00192029010808: UR CUS W JIGS 4.5 mm Torque -4, Tip +11
• 00192029010792: UL CUS W JIGS 4.5 mm Torque -4, Tip +11
• 00192029010785: LO BI CW W JIGS 4.0 mm Torque -20, Tip 0
• 00192029010778: LO BI CCW W JIGS 4.0 mm Torque -20, Tip 0
• 00192029010761: LR CUS W JIGS 4.0 mm Torque -11, Tip +5
• 00192029010754: LL CUS W JIGS 4.0 mm Torque -11, Tip +5
• 00192029010747: UP BI CW W JIGS 4.0 mm Torque -7, Tip 0
• 00192029010730: UP BI CCW W JIGS 4.0 mm Torque -7, Tip 0
• 00192029010723: UR CEN W JIGS 4.0 mm Torque +12, Tip +5
• 00192029010716: UL CEN W JIGS 4.0 mm Torque +12, Tip +5
• 00192029010709: LR ANT W JIGS 3.5 mm Torque -1, Tip +2
• 00192029010693: LL ANT W JIGS 3.5 mm Torque -1, Tip +2
• 00192029010662: UR LAT W JIGS 3.5 mm Torque +8, Tip +9
• 00192029010655: UL LAT W JIGS 3.5 mm Torque +8, Tip +9