| Primary Device ID | 75402950390035 |
| NIH Device Record Key | ed9ea4da-cc3b-4d5a-afbf-990e25bba8c0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SPEED D-Wire - Nickel Titanium |
| Version Model Number | 75402950300034 |
| Company DUNS | 203297635 |
| Company Name | Hespeler Orthodontics Limited |
| 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 | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 75402950300034 [Primary] |
| GS1 | 75402950390035 [Unit of Use] |
| 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 | 2022-11-18 |
| Device Publish Date | 2022-11-10 |
| 75402950490117 - SPEED Split Stop | 2023-06-22 |
| 75402950090027 - SPEED Bracket | 2023-03-21 |
| 75402950090034 - SPEED Bracket | 2023-03-21 |
| 75402950190116 - SPEED Single Buccal Tube | 2023-03-21 |
| 75402950190123 - SPEED Single Buccal Tube | 2023-03-21 |
| 75402950190130 - SPEED Double Buccal Tube | 2023-03-21 |
| 75402950190147 - SPEED PE Mini Buccal Tube | 2023-03-21 |
| 75402950190154 - SPEED Double Buccal Tube | 2023-03-21 |