| Primary Device ID | 10190886015223 |
| NIH Device Record Key | 38cf7872-9185-4023-8b6a-370ba00481b0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | G&H ORTHODONTICS® |
| Version Model Number | 125-U3-8RK-V |
| Company DUNS | 831465641 |
| Company Name | G & H WIRE COMPANY, INC. |
| Device Count | 5 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00190886015226 [Unit of Use] |
| GS1 | 10190886015223 [Primary] |
| NJM | Bracket, Ceramic, 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 | 2019-12-19 |
| Device Publish Date | 2019-12-11 |
| 10190886015605 | AGILITY® CERAMIC BRACKET SYSTEM MBT PRESCRIPTION .022 FULL CASE HOOKS ON 3,4,5 (20 BRACKETS) |
| 10190886015599 | AGILITY® CERAMIC BRACKET SYSTEM MBT PRESCRIPTION .018 FULL CASE HOOKS ON 3,4,5 (20 BRACKETS) |
| 10190886015582 | AGILITY® CERAMIC MBT .018 UR4/5 HK -7°T 0°A BRACKETS |
| 10190886015575 | AGILITY® CERAMIC MBT .018 UL4/5 HK -7°T 0°A BRACKETS |
| 10190886015568 | AGILITY® CERAMIC MBT .022 UR4/5 HK -7°T 0°A BRACKETS |
| 10190886015551 | AGILITY® CERAMIC MBT .022 UL4/5 HK -7°T 0°A BRACKETS |
| 10190886015544 | AGILITY® CERAMIC MBT .018 UR3 HK -7°T +8°A BRACKETS |
| 10190886015537 | AGILITY® CERAMIC MBT .018 UL3 HK -7°T +8°A BRACKETS |
| 10190886015520 | AGILITY® CERAMIC MBT .022 UR3 HK -7°T +8°A BRACKETS |
| 10190886015513 | AGILITY® CERAMIC MBT .022 UL3 HK -7°T +8°A BRACKETS |
| 10190886015506 | AGILITY® CERAMIC MBT .018 UR2 +10°T +8°A BRACKETS |
| 10190886015490 | AGILITY® CERAMIC MBT .018 UL2 +10°T +8°A BRACKETS |
| 10190886015483 | AGILITY® CERAMIC MBT .022 UR2 +10°T +8°A BRACKETS |
| 10190886015476 | AGILITY® CERAMIC MBT .022 UL2 +10°T +8°A BRACKETS |
| 10190886015469 | AGILITY® CERAMIC MBT .018 UR1 +17°T +4°A BRACKETS |
| 10190886015452 | AGILITY® CERAMIC MBT .018 UL1 +17°T +4°A BRACKETS |
| 10190886015445 | AGILITY® CERAMIC MBT .022 UR1 +17°T +4°A BRACKETS |
| 10190886015438 | AGILITY® CERAMIC MBT .022 UL1 +17°T +4°A BRACKETS |
| 10190886015421 | AGILITY® CERAMIC MBT .018 LR5 HK -17°T 0°A BRACKETS |
| 10190886015414 | AGILITY® CERAMIC MBT .018 LL5 HK -17°T 0°A BRACKETS |
| 10190886015407 | AGILITY® CERAMIC MBT .022 LR5 HK -17°T 0°A BRACKETS |
| 10190886015391 | AGILITY® CERAMIC MBT .022 LL5 HK -17°T 0°A BRACKETS |
| 10190886015384 | AGILITY® CERAMIC MBT .018 LR4 HK -12°T 0°A BRACKETS |
| 10190886015377 | AGILITY® CERAMIC MBT .018 LL4 HK -12°T 0°A BRACKETS |
| 10190886015360 | AGILITY® CERAMIC MBT .022 LR4 HK -12°T 0°A BRACKETS |
| 10190886015353 | AGILITY® CERAMIC MBT .022 LL4 HK -12°T 0°A BRACKETS |
| 10190886015346 | AGILITY® CERAMIC MBT .018 LR3 HK -6°T +3°A BRACKETS |
| 10190886015339 | AGILITY® CERAMIC MBT .018 LL3 HK -6°T +3°A BRACKETS |
| 10190886015322 | AGILITY® CERAMIC MBT .022 LR3 HK -6°T +3°A BRACKETS |
| 10190886015315 | AGILITY® CERAMIC MBT .022 LL3 HK -6°T +3°A BRACKETS |
| 10190886015308 | AGILITY® CERAMIC MBT .018 L1/2 -6°T 0°A BRACKETS |
| 10190886015292 | AGILITY® CERAMIC MBT .022 L1/2 -6°T 0°A BRACKETS |
| 10190886015285 | AGILITY® CERAMIC BRACKET SYSTEM ROTH PRESCRIPTION .018 FULL CASE HOOKS ON 3,4,5 (20 BRACKETS) |
| 10190886015278 | AGILITY® CERAMIC BRACKET SYSTEM ROTH PRESCRIPTION .022 FULL CASE HOOKS ON 3,4,5 (20 BRACKETS) |
| 10190886015261 | AGILITY® CERAMIC ROTH .018 UR4/5 HK -7°T 0°A BRACKETS |
| 10190886015254 | AGILITY® CERAMIC ROTH .018 UL4/5 HK -7°T 0°A BRACKETS |
| 10190886015247 | AGILITY® CERAMIC ROTH .022 UR4/5 HK -7°T 0°A BRACKETS |
| 10190886015230 | AGILITY® CERAMIC ROTH .022 UL4/5 HK -7°T 0°A BRACKETS |
| 10190886015223 | AGILITY® CERAMIC ROTH .018 UR3 HK 0°T +11°A 4°R BRACKETS |
| 10190886015216 | AGILITY® CERAMIC ROTH .018 UL3 HK 0°T +11°A 4°R BRACKETS |
| 10190886015209 | AGILITY® CERAMIC ROTH .022 UR3 HK 0°T +11°A 4°R BRACKETS |
| 10190886015193 | AGILITY® CERAMIC ROTH .022 UL3 HK 0°T +11°A 4°R BRACKETS |
| 10190886015186 | AGILITY® CERAMIC ROTH .018 UR2 +8°T +9°A BRACKETS |
| 10190886015179 | AGILITY® CERAMIC ROTH .018 UL2 +8°T +9°A BRACKETS |
| 10190886015162 | AGILITY® CERAMIC ROTH .022 UR2 +8°T +9°A BRACKETS |
| 10190886015155 | AGILITY® CERAMIC ROTH .022 UL2 +8°T +9°A BRACKETS |
| 10190886015148 | AGILITY® CERAMIC ROTH .018 UR1 +12°T +5°A BRACKETS |
| 10190886015131 | AGILITY® CERAMIC ROTH .018 UL1 +12°T +5°A BRACKETS |
| 10190886015124 | AGILITY® CERAMIC ROTH .022 UR1 +12°T +5°A BRACKETS |
| 10190886015117 | AGILITY® CERAMIC ROTH .022 UL1 +12°T +5°A BRACKETS |