| Primary Device ID | 06945630108761 |
| NIH Device Record Key | 1eb5e7d4-2d99-42f3-a43e-a605b497398c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Sterilance Press Pressure Activated Safety Lancet |
| Version Model Number | 05-052818 |
| Company DUNS | 421141183 |
| 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 | false |
| 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 | 06945630108761 [Unit of Use] |
| GS1 | 16945630108768 [Primary] |
| GS1 | 36945630108762 [Package] Contains: 16945630108768 Package: CASE [1000 Units] In Commercial Distribution |
| FMK | Lancet, Blood |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-12-10 |
| Device Publish Date | 2020-12-02 |
| 06945630108761 | Sterilance Press Pressure Activated Safety Lancet,28G 1.8mm,100Lancets/box |
| 06945630109058 | Sterilance Press Pressure Activated Safety Lancet,28G 1.8mm, 25Lancets |
| 06945630109126 | Sterilance Press Pressure Activated Safety Lancet,2500Pcs/Carton,25G 1.8mm |
| 06945630108778 | Sterilance Press Pressure Activated Safety Lancet,26G 1.8mm,100Lancets/box |