| Primary Device ID | 08800046046602 |
| NIH Device Record Key | b1aac286-980c-4e09-9abf-17ffc36e0d4b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SN02-1018 |
| Version Model Number | SN02-1018 |
| Company DUNS | 694828541 |
| Company Name | GNI Co.,Ltd |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08800046046602 [Primary] |
| ECO | Spring, 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 | 2024-06-12 |
| Device Publish Date | 2024-06-04 |
| 08800046051309 - SSBC-M22-464G | 2024-06-26 |
| 08800046051316 - SSBC-M22-364G | 2024-06-26 |
| 08800046051323 - SSBC-M22-264G | 2024-06-26 |
| 08800046051330 - SSBC-M22-164G | 2024-06-26 |
| 08800046051385 - SSBC-M22-1M44G | 2024-06-26 |
| 08800046027540 - IES1-1001 | 2024-06-12 |
| 08800046045896 - P01-01 | 2024-06-12 |
| 08800046046602 - SN02-1018 | 2024-06-12 |
| 08800046046602 - SN02-1018 | 2024-06-12 |