| Primary Device ID | 06970469418835 |
| NIH Device Record Key | 923f9ff1-895b-4faa-a3c2-b79ad6f76653 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 05Y Metal Self-Ligating Tube -10 UL/LR |
| Version Model Number | TB05Y-V |
| Company DUNS | 412892520 |
| Company Name | Zhejiang Headway Medical Equipment Co., Ltd |
| 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 | 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 | 06970469418835 [Primary] |
| DZD | Tube, Orthodontic |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[06970469418835]
Sound Waves
[06970469418835]
Sound Waves
[06970469418835]
Sound Waves
[06970469418835]
Sound Waves
[06970469418835]
Sound Waves
[06970469418835]
Sound Waves
[06970469418835]
Sound Waves
[06970469418835]
Sound Waves
[06970469418835]
Sound Waves
[06970469418835]
Sound Waves
[06970469418835]
Sound Waves
[06970469418835]
Sound Waves
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-12-04 |
| Device Publish Date | 2025-11-26 |
| 06970469419214 | PK OF 100 |
| 06970469418835 | PK OF 5 |