Tip-Edge PLUS Stainless Steel Brackets

GUDID 00192029011485

UL LAT W JIGS 4.0 mm

TP ORTHODONTICS INC

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• Primary Device ID: 00192029011485
• NIH Device Record Key: 18d2d4a8-21f8-46f8-ab30-3fe61104b037
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tip-Edge PLUS Stainless Steel Brackets
• Version Model Number: 296-641
• 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

Customer Support Contacts

• Phone: +1(219)785-2591
• Email: nicholas.smith@tportho.com
• Phone: +1(219)785-2591
• Email: nicholas.smith@tportho.com
• Phone: +1(219)785-2591
• Email: nicholas.smith@tportho.com
• Phone: +1(219)785-2591
• Email: nicholas.smith@tportho.com
• Phone: +1(219)785-2591
• Email: nicholas.smith@tportho.com
• Phone: +1(219)785-2591
• Email: nicholas.smith@tportho.com
• Phone: +1(219)785-2591
• Email: nicholas.smith@tportho.com
• Phone: +1(219)785-2591
• Email: nicholas.smith@tportho.com
• Phone: +1(219)785-2591
• Email: nicholas.smith@tportho.com
• Phone: +1(219)785-2591
• Email: nicholas.smith@tportho.com
• Phone: +1(219)785-2591
• Email: nicholas.smith@tportho.com
• Phone: +1(219)785-2591
• Email: nicholas.smith@tportho.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00192029011485 [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: 2022-03-09
• Device Publish Date: 2022-03-01

On-Brand Devices [Tip-Edge PLUS Stainless Steel Brackets]

• 00192029017456: UP BI CW W JIGS 4.5 mm
• 00192029017449: UP BI CCW W JIGS 4.5 mm
• 00192029017432: UP BI CW W JIGS 3.5 mm
• 00192029017425: UP BI CCW W JIGS 3.5 mm
• 00192029017418: LO BI CW W JIGS 4.5 mm
• 00192029017401: LO BI CCW W JIGS 4.5 mm
• 00192029017395: LO BI CW W JIGS 3.5 mm
• 00192029017388: LO BI CCW W JIGS 3.5 mm
• 00192029017371: LO BI CW W JIGS 4.5 mm
• 00192029017364: LO BI CCW W JIGS 4.5 mm
• 00192029017357: UR CEN W JIGS 3.5 mm
• 00192029017340: UL CEN W JIGS 3.5 mm
• 00192029017333: Patient Kit 4 BI EXT
• 00192029017326: Patient Kit UP/LO EXT W Jigs
• 00192029017319: Patient Kit UP/LO 5-5 W Tubes/
• 00192029017302: Patient Kit UP/LO 5-5 W Tubes
• 00192029011683: Patient Kit SPEC JIG LO OF
• 00192029011676: LO BI CW W JIGS 4.0 mm
• 00192029011669: LO BI CW W UNIV JIGS
• 00192029011645: UR CUS W JIGS 4.0 mm
• 00192029011638: UL CUS W JIGS 4.0 mm
• 00192029011621: LO BI CCW W JIGS 4.0 mm
• 00192029011607: Upper Bicuspid - CW -7 Torque, 0
• 00192029011591: Upper Bicuspid - CCW -7 Torque, 0
• 00192029011577: UR CUS W JIGS 5.0 mm
• 00192029011560: UL CUS W JIGS 5.0 mm
• 00192029011553: UR CEN W JIGS 4.5 mm
• 00192029011546: UL CEN W JIGS 4.5 mm
• 00192029011492: UR LAT W JIGS 4.0 mm
• 00192029011478: LO BI CCW W UNIV JIGS
• 00192029011423: LO BI CW
• 00192029011409: LO BI CCW
• 00192029011393: LR CUS W JIGS 5.0 mm
• 00192029011386: LL CUS W JIGS 5.0 mm
• 00192029011379: LR CUS W JIGS 4.5 mm
• 00192029011362: LL CUS W JIGS 4.5 mm
• 00192029011355: UR CUS W JIGS 4.5 mm
• 00192029011348: UL CUS W JIGS 4.5 mm
• 00192029011331: LO BI CW W JIGS 4.0 mm
• 00192029011324: LO BI CCW W JIGS 4.0 mm
• 00192029011317: LR CUS W JIGS 4.0 mm
• 00192029011300: LL CUS W JIGS 4.0 mm
• 00192029011294: LR ANT W JIGS 4.0 mm
• 00192029011287: LL ANT W JIGS 4.0 mm
• 00192029011270: UP BI CW W JIGS 4.0 mm
• 00192029011263: UP BI CCW W JIGS 4.0 mm
• 00192029011256: UR CEN W JIGS 4.0 mm
• 00192029011249: UL CEN W JIGS 4.0 mm
• 00192029011232: LO BI CW W JIGS 3.5 mm
• 00192029011225: LO BI CCW W JIGS 3.5 mm