Nu-Edge Bracket

GUDID 00192029010396

LO UNIV 1st BI NO HK VERTICAL SLOT

TP ORTHODONTICS INC

Orthodontic bracket, metal

• Primary Device ID: 00192029010396
• NIH Device Record Key: 57eab90e-af53-4fc4-b472-3036752f7d4f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nu-Edge Bracket
• Version Model Number: 293-829
• 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
• 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	00192029010396 [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: 2022-02-09
• Device Publish Date: 2022-02-01

On-Brand Devices [Nu-Edge Bracket]

• 00192029046760: LO UNIV 1st BI NO HK VERTICAL SLOT
• 00192029046647: LR 2nd BI W/DISTAL HK VERTICAL SLOT
• 00192029046630: LL 2nd BI W/DISTAL HK VERTICAL SLOT
• 00192029046586: LR 1st BI W/DISTAL HK VERTICAL SLOT
• 00192029046579: LL 1st BI W/DISTAL HK VERTICAL SLOT
• 00192029046562: LO UNIV 1st BI NO HK VERTICAL SLOT
• 00192029046517: LL CUS W/DISTAL HK VERTICAL SLOT
• 00192029046487: LR CUS NO HK VERTICAL SLOT
• 00192029046425: UR BI W/MESIAL HK VERTICAL SLOT
• 00192029046364: UR CUS W/DISTAL HK VERTICAL SLOT
• 00192029046326: UR CUS NO HK VERTICAL SLOT
• 00192029046227: LO UNIV BI NO HK
• 00192029046173: UP UNIV BI W 188 BASE NO HK
• 00192029046128: UP UNIV CEN
• 00192029046081: UL LAT
• 00192029046074: UR LAT
• 00192029046067: UL LAT
• 00192029046050: UR CEN
• 00192029046043: UL CEN
• 00192029045992: LR 2nd BI W/HK
• 00192029045985: LL 2nd BI W/HK
• 00192029045978: LR 1st BI W/HK
• 00192029045954: LR 1st BI W/HK
• 00192029045947: LL 1st BI W/HK
• 00192029045930: LO UNIV 2nd BI NO HK
• 00192029045916: LO UNIV 1st BI NO HK
• 00192029023969: LO UNIV 2nd BI NO HK VERTICAL SLOT
• 00192029023952: LO UNIV 1st BI NO HK VERTICAL SLOT
• 00192029023945: LR 2nd BI W/DISTAL HK VERTICAL SLOT
• 00192029023938: LL 2nd BI W/DISTAL HK VERTICAL SLOT
• 00192029023921: LR 1st BI W/DISTAL HK VERTICAL SLOT
• 00192029023914: LL 1st BI W/DISTAL HK VERTICAL SLOT
• 00192029023891: LR 1st BI W/DISTAL HK VERTICAL SLOT
• 00192029023884: LL 1st BI W/DISTAL HK VERTICAL SLOT
• 00192029023860: LL CUS NO HK VERTICAL SLOT
• 00192029023846: UL CUS NO HK VERTICAL SLOT
• 00192029023839: UL BI W/HK
• 00192029023822: UP UNIV BI W 188 BASE NO HK
• 00192029023808: LR 2nd BI W/HK
• 00192029023792: LL 2nd BI W/HK
• 00192029023778: LL 1st BI W/HK
• 00192029015599: LO UNIV 1st BI NO HK VERTICAL SLOT
• 00192029015582: LR CUS W/DISTAL HK VERTICAL SLOT
• 00192029015575: LL CUS W/DISTAL HK VERTICAL SLOT
• 00192029015568: UR CUS W/DISTAL HK VERTICAL SLOT
• 00192029015551: UL CUS W/DISTAL HK VERTICAL SLOT
• 00192029010419: UR LAT VERTICAL SLOT
• 00192029010402: UL LAT VERTICAL SLOT
• 00192029010396: LO UNIV 1st BI NO HK VERTICAL SLOT
• 00192029010358: LR CUS NO HK