| Primary Device ID | 36945630108922 |
| NIH Device Record Key | 91bf31d7-db82-4efa-8fdd-81e312e40de7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SteriLance Neoheel Heel Incision Safety Lancet |
| Version Model Number | 05-106514 |
| Company DUNS | 421141183 |
| 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 | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06945630108921 [Unit of Use] |
| GS1 | 16945630108928 [Primary] |
| GS1 | 36945630108922 [Package] Contains: 16945630108928 Package: case [200 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 | 2020-12-29 |
| Device Publish Date | 2020-12-21 |
| 36945630109042 | SteriLance Neoheel Heel Incision Safety Lancet,2.0*3.0mm,50Lancets/box |
| 36945630109035 | SteriLance Neoheel Heel Incision Safety Lancet,1.0*2.5mm,50Lancets/box |
| 36945630109028 | SteriLance Neoheel Heel Incision Safety Lancet,0.85*1.75mm,50Lancets/box |
| 36945630108922 | SteriLance Neoheel Heel Incision Safety Lancet,0.65*1.40mm,50Lancets/box |