| Primary Device ID | 00190886271707 |
| NIH Device Record Key | 9ffe1265-33ed-4663-b877-1e8dd977388b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | G&H ORTHODONTICS ® |
| Version Model Number | 131-U3-2LK0-V |
| Company DUNS | 831465641 |
| Company Name | G & H Wire Company, Inc. |
| Device Count | 5 |
| 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 | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(317)346-6655 |
| orders@ghortho.com | |
| Phone | +1(317)346-6655 |
| orders@ghortho.com | |
| Phone | +1(317)346-6655 |
| orders@ghortho.com | |
| Phone | +1(317)346-6655 |
| orders@ghortho.com | |
| Phone | +1(317)346-6655 |
| orders@ghortho.com | |
| Phone | +1(317)346-6655 |
| orders@ghortho.com | |
| Phone | +1(317)346-6655 |
| orders@ghortho.com | |
| Phone | +1(317)346-6655 |
| orders@ghortho.com | |
| Phone | +1(317)346-6655 |
| orders@ghortho.com | |
| Phone | +1(317)346-6655 |
| orders@ghortho.com | |
| Phone | +1(317)346-6655 |
| orders@ghortho.com | |
| Phone | +1(317)346-6655 |
| orders@ghortho.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00190886271707 [Unit of Use] |
| GS1 | 10190886271704 [Primary] |
| EJF | BRACKET, METAL, ORTHODONTIC |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-03-09 |
| Device Publish Date | 2026-02-27 |
| 10190886271872 | AURALIS MBT .022 HK/3 W/CASE |
| 10190886271865 | AURALIS MBT .022 HK/345 W/CASE |
| 00190886271851 | AURALIS MBT .022 LL5 HK -22°T 0°A 5PK |
| 00190886271844 | AURALIS MBT .022 LR5 HK -22°T 0°A 5PK |
| 00190886271837 | AURALIS MBT .022 LO4 -12°T 0°A 5PK |
| 00190886271820 | AURALIS MBT .022 LL4 HK -12°T 0°A 5PK |
| 00190886271813 | AURALIS MBT .022 LR4 HK -12°T 0°A 5PK |
| 00190886271806 | AURALIS MBT .022 LL3 HK -6°T +3°A 5PK |
| 00190886271790 | AURALIS MBT .022 LR3 HK -6°T +3°A 5PK |
| 00190886271783 | AURALIS MBT .022 LL3 HK 0°T +3°A 5PK |
| 00190886271776 | AURALIS MBT .022 LR3 HK 0°T +3°A 5PK |
| 00190886271769 | AURALIS MBT .022 L1/2 -6°T 0°A 5PK |
| 00190886271752 | AURALIS MBT .022 UP4/5 -7°T 0°A 5PK |
| 00190886271745 | AURALIS MBT .022 UL4/5 HK -7°T 0°A 5PK |
| 00190886271738 | AURALIS MBT .022 UR4/5 HK -7°T 0°A 5PK |
| 00190886271721 | AURALIS MBT .022 UL3 HK -7°T +8°A 5PK |
| 00190886271714 | AURALIS MBT .022 UR3 HK -7°T +8°A 5PK |
| 00190886271707 | AURALIS MBT .022 UL3 HK 0°T +8°A 5PK |
| 00190886271691 | AURALIS MBT .022 UR3 HK 0°T +8°A 5PK |
| 00190886271684 | AURALIS MBT .022 UL2 +10°T +8°A 5PK |
| 00190886271677 | AURALIS MBT .022 UR2 +10°T +8°A 5PK |
| 00190886271660 | AURALIS MBT .022 UL1 +17°T +4°A 5PK |
| 00190886271653 | AURALIS MBT .022 UR1 +17°T +4°A 5PK |
| 10190886271643 | AURALIS MBT .018 HK/3 W/CASE |
| 10190886271636 | AURALIS MBT .018 HK/345 W/CASE |
| 00190886271622 | AURALIS MBT .018 LL5 HK -22°T 0°A 5PK |
| 00190886271615 | AURALIS MBT .018 LR5 HK -22°T 0°A 5PK |
| 00190886271608 | AURALIS MBT .018 LO4 -12°T 0°A 5PK |
| 00190886271592 | AURALIS MBT .018 LL4 HK -12°T 0°A 5PK |
| 00190886271585 | AURALIS MBT .018 LR4 HK -12°T 0°A 5PK |
| 00190886271578 | AURALIS MBT .018 LL3 HK -6°T +3°A 5PK |
| 00190886271561 | AURALIS MBT .018 LR3 HK -6°T +3°A 5PK |
| 00190886271554 | AURALIS MBT .018 LL3 HK 0°T +3°A 5PK |
| 00190886271547 | AURALIS MBT .018 LR3 HK 0°T +3°A 5PK |
| 00190886271530 | AURALIS MBT .018 L1/2 -6°T 0°A 5PK |
| 00190886271523 | AURALIS MBT .018 UP4/5 -7°T 0°A 5PK |
| 00190886271516 | AURALIS MBT .018 UR4/5 HK -7°T 0°A 5PK |
| 00190886271509 | AURALIS MBT .018 UL4/5 HK -7°T 0°A 5PK |
| 00190886271493 | AURALIS MBT .018 UL3 HK -7°T +8°A 5PK |
| 00190886271486 | AURALIS MBT .018 UR3 HK -7°T +8°A 5PK |
| 00190886271479 | AURALIS MBT .018 UL3 HK 0°T +8°A 5PK |
| 00190886271462 | AURALIS MBT .018 UR3 HK 0°T +8°A 5PK |
| 00190886271455 | AURALIS MBT .018 UL2 +10°T +8°A 5PK |
| 00190886271448 | AURALIS MBT .018 UR2 +10°T +8°A 5PK |
| 00190886271431 | AURALIS MBT .018 UL1 +17°T +4°A 5PK |
| 00190886271424 | AURALIS MBT .018 UR1 +17°T +4°A 5PK |
| 10190886271414 | AURALIS ROTH .022 HK/3 W/CASE |
| 10190886271407 | AURALIS ROTH .022 HK/345 W/CASE |
| 00190886271394 | AURALIS ROTH .022 LL5 HK -22°T 0°A 5PK |
| 00190886271387 | AURALIS ROTH .022 LR5 HK -22°T 0°A 5PK |