| Primary Device ID | 00810152820254 |
| NIH Device Record Key | 94a84f16-fa07-4b6e-8694-bfec4e0cedbf |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Alpha Wires |
| Version Model Number | 601-02 |
| Company DUNS | 085719913 |
| Company Name | Ortho Pro Dent LLC |
| 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 | false |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | 941-402-6504 |
| edward@orthoprodent.com | |
| Phone | 941-402-6504 |
| edward@orthoprodent.com | |
| Phone | 941-402-6504 |
| edward@orthoprodent.com | |
| Phone | 941-402-6504 |
| edward@orthoprodent.com | |
| Phone | 941-402-6504 |
| edward@orthoprodent.com | |
| Phone | 941-402-6504 |
| edward@orthoprodent.com | |
| Phone | 941-402-6504 |
| edward@orthoprodent.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810152820254 [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 | 2024-11-13 |
| Device Publish Date | 2024-11-05 |
| 00810152820094 | Orthodontic Stainless steel archwire U 0.012": orthodontic Stainless steel Archwires size 0.012" |
| 00810152820087 | NITI super elastic archwire U 0.012": Orthodontic NITI super elastic archwire, 0.012" round ,up |
| 00810152820261 | Orthodontic NITI super elastic archwire, 0.014" round ,Upper ,10 pcs |
| 00810152820254 | Orthodontic NITI super elastic archwire, 0.012" round ,lower ,10 pcs |