| Primary Device ID | 20190886033385 |
| NIH Device Record Key | 1dcfe65b-79c9-440d-8d31-93aaf082ac50 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ENCHANTED SERIES |
| Version Model Number | 38HVAM |
| Company DUNS | 831465641 |
| Company Name | G & H Wire Company, Inc. |
| Device Count | 100 |
| 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 | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | true |
| 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 | |
| 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 | 00190886033381 [Unit of Use] |
| GS1 | 10190886033388 [Primary] |
| GS1 | 20190886033385 [Package] Contains: 10190886033388 Package: [50 Units] In Commercial Distribution |
| ECI | Band, elastic, 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 | 2024-04-25 |
| Device Publish Date | 2024-04-17 |
| 20190886033460 | ENCHANTED SER AMB 5/16 X-HV ELAST |
| 20190886033453 | ENCHANTED SER AMB 5/16 MD ELAST |
| 20190886033446 | ENCHANTED SER COL 5/16 MD ELAST |
| 20190886033439 | ENCHANTED SER AMB 5/16 LT ELAST |
| 20190886033422 | ENCHANTED SER AMB 5/16 HV ELAST |
| 20190886033415 | ENCHANTED SER COL 5/16 HV ELAST |
| 20190886033408 | ENCHANTED SER AMB 3/8 MD ELAST |
| 20190886033392 | ENCHANTED SER AMB 3/8 LT ELAST |
| 20190886033385 | ENCHANTED SER AMB 3/8 HV ELAST |
| 20190886033378 | ENCHANTED SER AMB 3/16 X-HV ELAST |
| 20190886033361 | ENCHANTED SER AMB 3/16 MD ELAST |
| 20190886033354 | ENCHANTED SER COL 3/16 MD ELAST |
| 20190886033347 | ENCHANTED SER AMB 3/16 LT ELAST |
| 20190886033330 | ENCHANTED SER AMB 3/16 HV ELAST |
| 20190886033323 | ENCHANTED SER COL 3/16 HV ELAST |
| 20190886033316 | ENCHANTED SER AMB 1/8 MD ELAST |
| 20190886033309 | ENCHANTED SER COL 1/8 MD ELAST |
| 20190886033293 | ENCHANTED SER AMB 1/8 LT ELAST |
| 20190886033286 | ENCHANTED SER AMB 1/8 HV ELAST |
| 20190886033279 | ENCHANTED SER COL 1/8 HV ELAST |
| 20190886033262 | ENCHANTED SER AMB 1/4 X-HV ELAST |
| 20190886033255 | ENCHANTED SER AMB 1/4 MD ELAST |
| 20190886033248 | ENCHANTED SER COL 1/4 MD ELAST |
| 20190886033231 | ENCHANTED SER AMB 1/4 LT ELAST |
| 20190886033224 | ENCHANTED SER AMB 1/4 HV ELAST |