| Primary Device ID | 20190886242404 |
| NIH Device Record Key | e1ce63b7-7950-458c-a0a4-bea68f0f30c3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | G4 EUROPA NICKEL TITANIUM SOLO-PACK |
| Version Model Number | G4EFU116ACS |
| Company DUNS | 831465641 |
| Company Name | G & H Wire Company, 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 | 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 | |
| Phone | +1(317)346-6655 |
| orders@ghortho.com |
| Outer Diameter | 0.016 Inch |
| Outer Diameter | 0.016 Inch |
| Outer Diameter | 0.016 Inch |
| Outer Diameter | 0.016 Inch |
| Outer Diameter | 0.016 Inch |
| Outer Diameter | 0.016 Inch |
| Outer Diameter | 0.016 Inch |
| Outer Diameter | 0.016 Inch |
| Outer Diameter | 0.016 Inch |
| Outer Diameter | 0.016 Inch |
| Outer Diameter | 0.016 Inch |
| Outer Diameter | 0.016 Inch |
| Outer Diameter | 0.016 Inch |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10190886242407 [Primary] |
| GS1 | 20190886242404 [Package] Contains: 10190886242407 Package: [10 Units] In Commercial Distribution |
| DZC | WIRE, 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 | 2025-04-03 |
| Device Publish Date | 2025-03-26 |
| 20190886242770 | G4 NITI EFII UPR 018x025 SOLO-PACK |
| 20190886242763 | G4 NITI EFII UPR 018x025 W/STOPS SOLO-PACK |
| 20190886242756 | G4 NITI EFII UPR 018x018 W/STOPS SOLO-PACK |
| 20190886242749 | G4 NITI EFII UPR 017x025 SOLO-PACK |
| 20190886242732 | G4 NITI EFII UPR 017x025 DIMPLED SOLO-PACK |
| 20190886242725 | G4 NITI EFII UPR 017x025 W/STOPS SOLO-PACK |
| 20190886242718 | G4 NITI EFII UPR 017x017 W/STOPS SOLO-PACK |
| 20190886242701 | G4 NITI EFII UPR 016x025 SOLO-PACK |
| 20190886242695 | G4 NITI EFII UPR 016x022 SOLO-PACK |
| 20190886242688 | G4 NITI EFII UPR 016x022 DIMPLED SOLO-PACK |
| 20190886242671 | G4 NITI EFII UPR 016x022 W/STOPS SOLO-PACK |
| 20190886242664 | G4 NITI EFII UPR 016x016 SOLO-PACK |
| 20190886242657 | G4 NITI EFII UPR 016x016 W/STOPS SOLO-PACK |
| 20190886242640 | G4 NITI EFII UPR 014x025 SOLO-PACK |
| 20190886242633 | G4 NITI EFII UPR 014x025 W/STOPS SOLO-PACK |
| 20190886242626 | G4 NITI EFII UPR 021x025 SOLO-PACK |
| 20190886242619 | G4 NITI EFI UPR 021x025 SOLO-PACK |
| 20190886242602 | G4 NITI EFI UPR 020x020 SOLO-PACK |
| 20190886242596 | G4 NITI EFI UPR 019x025 SOLO-PACK |
| 20190886242589 | G4 NITI EFI UPR 019x025 DIMPLED SOLO-PACK |
| 20190886242572 | G4 NITI EFI UPR 019x025 W/STOPS SOLO-PACK |
| 20190886242565 | G4 NITI EFI UPR 018x025 SOLO-PACK |
| 20190886242558 | G4 NITI EFI UPR 018x018 SOLO-PACK |
| 20190886242541 | G4 NITI EFI UPR 017x025 SOLO-PACK |
| 20190886242534 | G4 NITI EFI UPR 017x025 DIMPLED SOLO-PACK |
| 20190886242527 | G4 NITI EFI UPR 017x025 W/STOPS SOLO-PACK |
| 20190886242510 | G4 NITI EFI UPR 016x022 SOLO-PACK |
| 20190886242503 | G4 NITI EFI UPR 016x022 DIMPLED SOLO-PACK |
| 20190886242497 | G4 NITI EFI UPR 016x022 W/STOPS SOLO-PACK |
| 20190886242480 | G4 NITI EFI UPR 016x016 SOLO-PACK |
| 20190886242473 | G4 NITI EFI UPR 014x025 SOLO-PACK |
| 20190886242466 | G4 NITI EFII UPR 020 SOLO-PACK |
| 20190886242459 | G4 NITI EFII UPR 020 DIMPLED SOLO-PACK |
| 20190886242442 | G4 NITI EFII UPR 018 SOLO-PACK |
| 20190886242435 | G4 NITI EFII UPR 018 W/STOPS SOLO-PACK |
| 20190886242428 | G4 NITI EFII UPR 016 SOLO-PACK |
| 20190886242411 | G4 NITI EFII UPR 016 DIMPLED SOLO-PACK |
| 20190886242404 | G4 NITI EFII UPR 016 W/STOPS SOLO-PACK |
| 20190886242398 | G4 NITI EFII UPR 014 SOLO-PACK |
| 20190886242381 | G4 NITI EFII UPR 014 W/STOPS SOLO-PACK |
| 20190886242374 | G4 NITI EFII UPR 013 SOLO-PACK |
| 20190886242367 | G4 NITI EFII UPR 012 SOLO-PACK |
| 20190886242350 | G4 NITI EFI UPR 020 SOLO-PACK |
| 20190886242343 | G4 NITI EFI UPR 018 SOLO-PACK |
| 20190886242336 | G4 NITI EFI UPR 018 DIMPLED SOLO-PACK |
| 20190886242329 | G4 NITI EFI UPR 018 W/STOPS SOLO-PACK |
| 20190886242312 | G4 NITI EFI UPR 016 SOLO-PACK |
| 20190886242305 | G4 NITI EFI UPR 016 DIMPLED SOLO-PACK |
| 20190886242299 | G4 NITI EFI UPR 016 W/STOPS SOLO-PACK |
| 20190886242282 | G4 NITI EFI UPR 014 SOLO-PACK |