Nu-Edge Self-Ligating CoCr Brackets

GUDID 00192029008010

UP & LO 5-5 CUS/BI W/HOOK

TP ORTHODONTICS INC

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• Primary Device ID: 00192029008010
• NIH Device Record Key: 1d3848b6-5509-4e15-851a-1cd802f62f74
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nu-Edge Self-Ligating CoCr Brackets
• Version Model Number: 293-291SL
• 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	00192029008010 [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 Self-Ligating CoCr Brackets]

• 00192029047514: UP/LO 5-5 CUS/BI W/HK W/JIGS
• 00192029019276: UR BI W/DISTAL HK
• 00192029019269: UL BI W/DISTAL HK
• 00192029019252: UR BI W/DISTAL HK
• 00192029019245: UL BI W/DISTAL HK
• 00192029019238: LR 1st BI W/DISTAL HK
• 00192029019221: LL 1st BI W/DISTAL HK
• 00192029019214: LR 1st BI W/DISTAL HK
• 00192029019207: LL 1st BI W/DISTAL HK
• 00192029019191: LR 2nd BI W/DISTAL HK
• 00192029019184: LL 2nd BI W/DISTAL HK
• 00192029019177: LR 2nd BI W/DISTAL HK
• 00192029019160: LL 2nd BI W/DISTAL HK
• 00192029019153: LR CUS W/DISTAL HK
• 00192029019146: LL CUS W/DISTAL HK
• 00192029019139: UP UNIV ANT
• 00192029019122: UP UNIV ANT
• 00192029019115: UR CUS W/DISTAL HK
• 00192029019108: UL CUS W/DISTAL HK
• 00192029019092: UR CUS W/DISTAL HK
• 00192029019085: UL CUS W/DISTAL HK
• 00192029019078: UR LAT
• 00192029019061: UL LAT
• 00192029019054: UR LAT
• 00192029019047: UL LAT
• 00192029019030: UR CEN
• 00192029019023: UL CEN
• 00192029019016: UR CEN
• 00192029019009: UP L CEN
• 00192029018897: LR CUS W/HK
• 00192029018880: LL CUS W/HK
• 00192029018873: LR CUS W/HK
• 00192029018866: LL CUS W/HK
• 00192029018859: LO UNIV ANT
• 00192029018842: LO UNIV ANT
• 00192029018835: UR BI W/HK
• 00192029018828: UL BI W/HK
• 00192029018811: UR BI W/HK
• 00192029018804: UL BI W/HK
• 00192029018798: UR CUS W/HK
• 00192029018781: UL CUS W/HK
• 00192029018774: UR CUS W/HK
• 00192029018767: UL CUS W/HK
• 00192029018750: UR LAT
• 00192029018743: UL LAT
• 00192029018736: UR LAT
• 00192029018729: UL LAT
• 00192029018712: UR CEN
• 00192029018705: UL CEN
• 00192029018699: UR CEN