| Primary Device ID | 36945630115029 |
| NIH Device Record Key | 04143d5e-205f-43d8-b099-7f3186efede0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Index Asurity Disposable Safety Scalpel |
| Version Model Number | 22-0422 |
| Company DUNS | 554434897 |
| Company Name | Sterilance Medical (Suzhou) Inc. |
| Device Count | 10 |
| 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 | true |
| 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 | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06945630115028 [Unit of Use] |
| GS1 | 16945630115025 [Primary] |
| GS1 | 36945630115029 [Package] Contains: 16945630115025 Package: [50 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 | 2022-12-08 |
| Device Publish Date | 2022-11-30 |
| 26945630125779 - PRESS DISPOSABLE SAFETY LANCET | 2024-05-09 |
| 36945630125752 - EXALANCE LDE4 Lancing Device | 2024-05-02 |
| 06945630125522 - STERiLANCE SteriHeel Plus Heel Incision Safety Lancet | 2024-04-17 |
| 26945630125120 - Disposable Safety Lancet Press2 | 2024-04-08 |
| 36945630121808 - neoheel | 2024-02-16 |
| 36945630121815 - neoheel | 2024-02-16 |
| 06945630121821 - neoheel | 2024-02-16 |
| 36945630124106 - neoheel | 2024-02-16 |