| Primary Device ID | 07908611207470 |
| NIH Device Record Key | 0f37a289-ddc6-4b18-a376-d37e3e2d0183 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ORTHOFLEXY ELASTOMERIC-MODULAR LIGATURE 10 TIES-RED |
| Version Model Number | 60.06.1102 |
| Company DUNS | 898330003 |
| Company Name | ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA |
| 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 | true |
| 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 | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07908611207470 [Primary] |
| 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 | 2025-11-28 |
| Device Publish Date | 2025-11-20 |
| 07908611207463 - ORTHOFLEXY ELASTOMERIC-MODULAR LIGATURE 10 TIES-BLUE | 2025-11-28 ORTHOFLEXY ELASTOMERIC-MODULAR LIGATURE 10 TIES-BLUE |
| 07908611207470 - ORTHOFLEXY ELASTOMERIC-MODULAR LIGATURE 10 TIES-RED | 2025-11-28ORTHOFLEXY ELASTOMERIC-MODULAR LIGATURE 10 TIES-RED |
| 07908611207470 - ORTHOFLEXY ELASTOMERIC-MODULAR LIGATURE 10 TIES-RED | 2025-11-28 ORTHOFLEXY ELASTOMERIC-MODULAR LIGATURE 10 TIES-RED |
| 07908611207487 - ORTHOFLEXY ELASTOMERIC-MODULAR LIGATURE 10 TIES-PINK | 2025-11-28 ORTHOFLEXY ELASTOMERIC-MODULAR LIGATURE 10 TIES-PINK |
| 07908611207494 - ORTHOFLEXY ELASTOMERIC-MODULAR LIGATURE 10 TIES-BLACK | 2025-11-28 ORTHOFLEXY ELASTOMERIC-MODULAR LIGATURE 10 TIES-BLACK |
| 07908611207500 - ORTHOFLEXY ELASTOMERIC-MODULAR LIGATURE 10 TIES-SEA GREEN | 2025-11-28 ORTHOFLEXY ELASTOMERIC-MODULAR LIGATURE 10 TIES-SEA GREEN |
| 07908611207517 - ORTHOFLEXY ELASTOMERIC-MODULAR LIGATURE 10 TIES-CRYSTAL GREEN | 2025-11-28 ORTHOFLEXY ELASTOMERIC-MODULAR LIGATURE 10 TIES-CRYSTAL GREEN |
| 07908611207524 - ORTHOFLEXY ELASTOMERIC-MODULAR LIGATURE 10 TIES-GREY | 2025-11-28 ORTHOFLEXY ELASTOMERIC-MODULAR LIGATURE 10 TIES-GREY |
| 07908611207531 - ORTHOFLEXY ELASTOMERIC-MODULAR LIGATURE 10 TIES-CRYSTAL | 2025-11-28 ORTHOFLEXY ELASTOMERIC-MODULAR LIGATURE 10 TIES-CRYSTAL |