| Primary Device ID | 07540295900164 |
| NIH Device Record Key | 4c687137-af8a-4a8c-abd4-f486e25b0632 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SPEED Split Stop Samples |
| Version Model Number | 07540295000253 |
| Company DUNS | 203297635 |
| Company Name | Hespeler Orthodontics Limited |
| Device Count | 20 |
| DM Exempt | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07540295000239 [Primary] |
| GS1 | 07540295000246 [Primary] |
| GS1 | 07540295000253 [Primary] |
| GS1 | 07540295900164 [Unit of Use] |
| GS1 | 75402950400031 [Previous] |
| GS1 | 75402950400109 [Previous] |
| GS1 | 75402950400116 [Previous] |
| ECN | Clamp, 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 | 2024-08-19 |
| Device Publish Date | 2024-08-09 |
| 07540295900010 - SPEED Bracket | 2024-08-19 |
| 07540295900027 - SPEED Buccal Tube Samples | 2024-08-19 |
| 07540295900034 - SPEED Convertible Buccal Tube | 2024-08-19 |
| 07540295900041 - SPEED Beta Titanium Archwire | 2024-08-19 |
| 07540295900058 - SPEED Coaxial Archwire | 2024-08-19 |
| 07540295900065 - SPEED D-Wire - Nickel Titanium | 2024-08-19 |
| 07540295900072 - SPEED D-Wire - Stainless Steel | 2024-08-19 |
| 07540295900089 - Hills Dual-Geometry Wire | 2024-08-19 |