| Primary Device ID | 36945630137618 |
| NIH Device Record Key | 1e68fbf3-7f6e-4a39-97b4-7792790c6f21 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | index Asurity |
| Version Model Number | Index Asurity 4# SS 23# |
| Company DUNS | 554434897 |
| Company Name | Sterilance Medical (Suzhou) Inc. |
| Device Count | 50 |
| 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 | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06945630137617 [Unit of Use] |
| GS1 | 16945630137614 [Primary] |
| GS1 | 36945630137618 [Package] Contains: 16945630137614 Package: [3 Units] In Commercial Distribution |
| GDX | Scalpel, One-Piece |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-09-03 |
| Device Publish Date | 2025-08-26 |
| 36945630137632 | Index Asurity 4# |
| 36945630137625 | Index Asurity 3# |
| 36945630139070 | Index Asurity 3# SS 13# |
| 36945630139063 | Index Asurity 3# SS 10# |
| 36945630137618 | Index Asurity 4# SS 23# |
| 36945630137601 | Index Asurity 4# SS 22# |
| 36945630137595 | Index Asurity 3# SS 15# |
| 36945630137588 | Index Asurity 3# SS 11# |