| Primary Device ID | 00190886256902 |
| NIH Device Record Key | c748e5d2-9098-4a8e-9ec4-04bda16bc13c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TRUEFORM |
| Version Model Number | SETFU1622ADX |
| Company DUNS | 831465641 |
| Company Name | G & H Wire Company, Inc. |
| Device Count | 10 |
| 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 |
| Height | 0.016 Inch |
| Width | 0.022 Inch |
| Height | 0.016 Inch |
| Width | 0.022 Inch |
| Height | 0.016 Inch |
| Width | 0.022 Inch |
| Height | 0.016 Inch |
| Width | 0.022 Inch |
| Height | 0.016 Inch |
| Width | 0.022 Inch |
| Height | 0.016 Inch |
| Width | 0.022 Inch |
| Height | 0.016 Inch |
| Width | 0.022 Inch |
| Height | 0.016 Inch |
| Width | 0.022 Inch |
| Height | 0.016 Inch |
| Width | 0.022 Inch |
| Height | 0.016 Inch |
| Width | 0.022 Inch |
| Height | 0.016 Inch |
| Width | 0.022 Inch |
| Height | 0.016 Inch |
| Width | 0.022 Inch |
| Height | 0.016 Inch |
| Width | 0.022 Inch |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00190886256902 [Unit of Use] |
| GS1 | 10190886256909 [Primary] |
| 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 |
| 00190886257145 | SE NITI TFII UPPER 016x022 |
| 00190886257138 | SE NITI TFII UPPER 016x016 |
| 00190886257121 | SE NITI TFII UPPER 016x016 |
| 00190886257114 | SE NITI TFII UPPER 021x025 |
| 00190886257107 | SE NITI TFII UP 021x025 DIMPLE |
| 00190886257091 | SE NITI TFII UPPER 021x025 |
| 00190886257084 | SE NITI TFI UP 021x025 DIMPLED |
| 00190886257077 | SE NITI TFI UP 021x025 DIMPLED |
| 00190886257060 | SE NITI TFI UPPER 021x025 |
| 00190886257053 | SE NITI TFI UPPER 020x020 |
| 00190886257046 | SE NITI TFI UPPER 020x020 |
| 00190886257039 | SE NITI TFI UPPER 019x025 |
| 00190886257022 | SE NITI TFI UP 019x025 DIMPLED |
| 00190886257015 | SE NITI TFI UP 019x025 DIMPLED |
| 00190886257008 | SE NITI TFI UPPER 019x025 |
| 00190886256995 | SE NITI TFI UPPER 018x025 |
| 00190886256988 | SE NITI TFI UP 018x025 DIMPLED |
| 00190886256971 | SE NITI TFI UPPER 018x018 |
| 00190886256964 | SE NITI TFI UPPER 018x018 |
| 00190886256957 | SE NITI TFI UP 017x025 DIMPLED |
| 00190886256940 | SE NITI TFI UP 017x025 DIMPLED |
| 00190886256933 | NITI TFI UPR 017x025 W/STPS |
| 00190886256926 | SE NITI TFI UPPER 017x025 |
| 00190886256919 | SE NITI TFI UPPER 016x025 |
| 00190886256902 | SE NITI TFI UP 016x022 DIMPLED |
| 00190886256896 | SE NITI TFI UP 016x022 DIMPLED |
| 00190886256889 | SE NITI TFI UPPER 016x022 |
| 00190886256872 | SE NITI TFI UPPER 016x022 |
| 00190886256865 | SE NITI TFI UP 016x016 DIMPLED |
| 00190886256858 | SE NITI TFI UPPER 014x025 |
| 00190886256841 | SE NITI TFI UPPER 014x020 |
| 00190886256834 | SE NITI TFII UP 016 DIMPLED |
| 00190886256827 | SE NITI TFII UPPER 014 |
| 00190886256810 | SE NITI TFI UPPER 020 |
| 00190886256803 | SE NITI TFI UPPER 018 |
| 00190886256797 | SE NITI TFI UPPER 018 |
| 00190886256780 | SE NITI TFI UPPER 016 |
| 00190886256773 | SE NITI TFI UP 016 DIMPLED |
| 00190886256766 | NITI TFI UPR 016 W/STOPS |
| 00190886256759 | SE NITI TFI UPPER 016 |
| 00190886256742 | SE NITI TFI UP 014 DIMPLED |
| 00190886256735 | SE NITI TFI UP 014 DIMPLED |
| 00190886256728 | NITI TFI UPR 014 W/STOPS |
| 00190886256711 | SE NITI TFI UPPER 014 |
| 00190886256704 | SE NITI TFI UPPER 012 |
| 00190886256698 | SE NITI TFI UP 012 DIMPLED |
| 00190886256681 | SE NITI TFI UPPER 012 |
| 00190886256674 | SE NITI TFII LO 019x025 DIMPLE |
| 00190886256667 | SE NITI TFII LOWER 017x025 |
| 00190886256650 | SE NITI TFII LOWER 016x022 |