Nu-Edge Cobalt Chromium Brackets

GUDID 00192029047019

UL LAT

TP ORTHODONTICS INC

Orthodontic bracket, metal

• Primary Device ID: 00192029047019
• NIH Device Record Key: ea13949e-a5c4-4e7c-ae19-7310c88350f9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nu-Edge Cobalt Chromium Brackets
• Version Model Number: 293-3161
• 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	00192029047019 [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 Cobalt Chromium Brackets]

• 00192029047811: LR 2BI HK NE II MBT 22OFF
• 00192029047804: LL 2BI HK NE II MBT 22OFF
• 00192029047507: UR LAT
• 00192029047491: UL LAT
• 00192029047484: UR LAT
• 00192029047477: UL LAT
• 00192029047460: UR CEN
• 00192029047453: UL CEN
• 00192029047446: UR CEN
• 00192029047439: UL CEN
• 00192029047422: LR 2nd BI W/DISTAL HK
• 00192029047415: LL 2nd BI W/DISTAL HK
• 00192029047408: LR 2nd BI W/DISTAL HK
• 00192029047392: LL 2nd BI W/DISTAL HK
• 00192029047385: LR 2nd BI NO HK
• 00192029047378: LL 2nd BI NO HK
• 00192029047361: LR 2nd BI NO HK
• 00192029047347: LR 1st BI W/DISTAL HK
• 00192029047330: LL 1st BI W/DISTAL HK
• 00192029047323: LR 1st BI W/DISTAL HK
• 00192029047316: LL 1st BI W/DISTAL HK
• 00192029047309: LR 1st BI NO HK
• 00192029047286: LR 1st BI NO HK
• 00192029047279: LL 1st BI NO HK
• 00192029047262: LR CUS W/DISTAL HK
• 00192029047255: LL CUS W/DISTAL HK
• 00192029047248: LR CUS W/DISTAL HK
• 00192029047231: LL CUS W/DISTAL HK
• 00192029047187: LO UNIV ANT
• 00192029047170: LO UNIV ANT
• 00192029047163: UR UNIV BI W/DISTAL HK
• 00192029047156: UL UNIV BI W/DISTAL HK
• 00192029047149: UR UNIV BI W/DISTAL HK
• 00192029047132: UL UNIV BI W/DISTAL HK
• 00192029047125: UP UNIV BI NO HK
• 00192029047118: UP UNIV BI NO HK
• 00192029047101: UR CUS W/DISTAL HK
• 00192029047095: UL CUS W/DISTAL HK
• 00192029047088: UR CUS W/DISTAL HK
• 00192029047071: UL CUS W/DISTAL HK
• 00192029047057: UL CUS NO HK
• 00192029047040: UR CUS NO HK
• 00192029047033: UL CUS NO HK
• 00192029047026: UR LAT
• 00192029047019: UL LAT
• 00192029047002: UR LAT
• 00192029046999: UL LAT
• 00192029046982: UR CEN
• 00192029046975: UL CEN
• 00192029046968: UR CEN