| Primary Device ID | 06975043365987 |
| NIH Device Record Key | 26e5ca23-e071-4edf-bd37-ee8dac06aa04 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ISRIE |
| Version Model Number | G3-G1708-19,G3-G1902-25,G3-G1506-25,G3-G2504-25,G3 |
| Company DUNS | 413885255 |
| Company Name | Hansfive (Hangzhou) Dental Technology 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06975043365987 [Primary] |
| EKS | File, Pulp Canal, Endodontic |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[06975043365987]
Dry Heat Sterilization
[06975043365987]
Dry Heat Sterilization
[06975043365987]
Dry Heat Sterilization
[06975043365987]
Dry Heat Sterilization
[06975043365987]
Dry Heat Sterilization
[06975043365987]
Dry Heat Sterilization
[06975043365987]
Dry Heat Sterilization
[06975043365987]
Dry Heat Sterilization
[06975043365987]
Dry Heat Sterilization
[06975043365987]
Dry Heat Sterilization
[06975043365987]
Dry Heat Sterilization
[06975043365987]
Dry Heat Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-01-15 |
| Device Publish Date | 2026-01-07 |