| Primary Device ID | 00190886155243 |
| NIH Device Record Key | 14f9e744-d002-404e-83f8-cda9b3580edd |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | HGSTPP |
| 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 | |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00190886155243 [Unit of Use] |
| GS1 | 10190886155240 [Primary] |
| DZB | Headgear, extraoral, 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 | 2025-04-08 |
| Device Publish Date | 2025-03-31 |
| 10190886051276 - NA | 2025-04-08 BLACK COATED FACEBOW, UNIV |
| 10190886051283 - NA | 2025-04-08 BLUE COATED FACEBOW, UNIV |
| 10190886051290 - NA | 2025-04-08 WHITE COATED FACEBOW, UNIV |
| 10190886051306 - NA | 2025-04-08 ORANGE COATED FACEBOW, UNIV |
| 10190886051313 - NA | 2025-04-08 DARK GREEN COATED FACEBOW, UNIV |
| 10190886051320 - NA | 2025-04-08 LIME GREEN COATED FACEBOW, UNIV |
| 10190886051337 - NA | 2025-04-08 YELLOW COATED FACEBOW, UNIV |
| 10190886051344 - NA | 2025-04-08 PURPLE COATED FACEBOW, UNIV |