| Primary Device ID | 20190886241643 |
| NIH Device Record Key | 5dde474d-1d3d-413b-96b3-7a6034974614 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | G4 NICKEL TITANIUM SOLO-PACK |
| Version Model Number | G4BF518AS |
| 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 | 0.018 Inch |
| Outer Diameter | 0.018 Inch |
| Outer Diameter | 0.018 Inch |
| Outer Diameter | 0.018 Inch |
| Outer Diameter | 0.018 Inch |
| Outer Diameter | 0.018 Inch |
| Outer Diameter | 0.018 Inch |
| Outer Diameter | 0.018 Inch |
| Outer Diameter | 0.018 Inch |
| Outer Diameter | 0.018 Inch |
| Outer Diameter | 0.018 Inch |
| Outer Diameter | 0.018 Inch |
| Outer Diameter | 0.018 Inch |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10190886241646 [Primary] |
| GS1 | 20190886241643 [Package] Contains: 10190886241646 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 |
| 20190886243623 | G4 NITI EX-LARGE LINGUAL UNIV 016x022 SOLO-PACK |
| 20190886243104 | G4 NITI SMALL LINGUAL UNIV. .016" SOLO-PACK |
| 20190886243098 | G4 NITI SMALL LINGUAL UNIV. .010" SOLO-PACK |
| 20190886243081 | G4 NITI SF UPR 018x025 SOLO-PACK |
| 20190886243074 | G4 NITI SF UPR 018x018 SOLO-PACK |
| 20190886243067 | G4 NITI SF UPR 016x022 SOLO-PACK |
| 20190886243050 | G4 NITI SF UPR 016x016 SOLO-PACK |
| 20190886243043 | G4 NITI SF UPR 020 SOLO-PACK |
| 20190886243036 | G4 NITI SF UPR 018 SOLO-PACK |
| 20190886243029 | G4 NITI SF UPR 016 SOLO-PACK |
| 20190886243012 | G4 NITI SF UPR 014 SOLO-PACK |
| 20190886243005 | G4 NITI SF UPR 012 SOLO-PACK |
| 20190886242992 | G4 NITI SF LWR 021x025 SOLO-PACK |
| 20190886242985 | G4 NITI SF LWR 018x025 SOLO-PACK |
| 20190886242978 | G4 NITI SF LWR 017x025 SOLO-PACK |
| 20190886242961 | G4 NITI SF LWR 016x022 SOLO-PACK |
| 20190886242954 | G4 NITI SF LWR 016x016 SOLO-PACK |
| 20190886242947 | G4 NITI SF LWR 020 SOLO-PACK |
| 20190886242930 | G4 NITI SF LWR 018 SOLO-PACK |
| 20190886242923 | G4 NITI SF LWR 016 SOLO-PACK |
| 20190886242916 | G4 NITI SF LWR 014 SOLO-PACK |
| 20190886242909 | G4 NITI SF LWR 012 SOLO-PACK |
| 20190886242893 | G4 NITI RCIII UPR 021x025 DIMPLED SOLO-PACK |
| 20190886242886 | G4 NITI RCI LWR 012 SOLO-PACK |
| 20190886242879 | G4 NITI RC EUROPA II UPR 016 SOLO-PACK |
| 20190886242862 | G4 NITI RC EUROPA II UPR 016 W/STOPS SOLO-PACK |
| 20190886242855 | G4 NITI RC EUROPA II UPR 013 W/STOPS SOLO-PACK |
| 20190886241643 | G4 NITI BFV 018 SOLO-PACK |
| 20190886241636 | G4 NITI BFV 016x022 SOLO-PACK |
| 20190886241629 | G4 NITI BFV 016x016 SOLO-PACK |
| 20190886241612 | G4 NITI BFV 012 SOLO-PACK |
| 20190886241605 | G4 NITI BFIV 016 DIMPLED SOLO-PACK |
| 20190886241599 | G4 NITI BFIII UPR 018x025 SOLO-PACK |
| 20190886241582 | G4 NITI BFIII UPR 018x018 SOLO-PACK |
| 20190886241575 | G4 NITI BFIII UPR 016x022 SOLO-PACK |
| 20190886241568 | G4 NITI BFIII UPR 016x016 SOLO-PACK |
| 20190886241551 | G4 NITI BFIII UPR 016 SOLO-PACK |
| 20190886241544 | G4 NITI BFIII UPR 016 W/STOPS SOLO-PACK |
| 20190886241537 | G4 NITI BFIII UPR 014 SOLO-PACK |
| 20190886241520 | G4 NITI BFIII UPR 014 W/STOPS SOLO-PACK |
| 20190886241513 | G4 NITI BFIII UPR 012 SOLO-PACK |
| 20190886241506 | G4 NITI BFIII LWR 021x025 SOLO-PACK |
| 20190886241490 | G4 NITI BFIII LWR 018x025 SOLO-PACK |
| 20190886241483 | G4 NITI BFIII LWR 018x018 SOLO-PACK |
| 20190886241476 | G4 NITI BFIII LWR 016x022 SOLO-PACK |
| 20190886241469 | G4 NITI BFIII LWR 016x016 SOLO-PACK |
| 20190886241452 | G4 NITI BFIII LWR 018 SOLO-PACK |
| 20190886241445 | G4 NITI BFIII LWR 016 SOLO-PACK |
| 20190886241438 | G4 NITI BFIII LWR 014 SOLO-PACK |
| 20190886241421 | G4 NITI BFIII LWR 012 SOLO-PACK |