| Primary Device ID | 36945630112967 |
| NIH Device Record Key | 15184be9-e25d-4158-b313-a31d00d49de0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Sterilance Lite3 |
| Version Model Number | 05-112818 |
| Company DUNS | 554434897 |
| Company Name | Sterilance Medical (Suzhou) Inc. |
| Device Count | 100 |
| 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 | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06945630112966 [Unit of Use] |
| GS1 | 16945630112963 [Primary] |
| GS1 | 36945630112967 [Package] Contains: 16945630112963 Package: [10 Units] In Commercial Distribution |
| FMK | Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-08-01 |
| Device Publish Date | 2022-07-22 |
| 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 |
| 26945630122846 - Soft | 2024-02-08 |
| 26945630122853 - Soft | 2024-02-08 |