| Primary Device ID | 36972857295142 |
| NIH Device Record Key | 91ac7587-1e2d-413e-aca0-3d9b169c36d0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Easydrip SafeGard Duo Safety Pen Needles |
| Version Model Number | HS |
| Company DUNS | 554500882 |
| Company Name | Sandstone Medical (Suzhou) Inc. |
| Device Count | 100 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06972857295141 [Unit of Use] |
| GS1 | 16972857295148 [Primary] |
| GS1 | 36972857295142 [Package] Contains: 16972857295148 Package: [8 Units] Discontinued: 2025-07-08 Not in Commercial Distribution |
| FMI | Needle, Hypodermic, Single Lumen |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-07-16 |
| Device Publish Date | 2025-07-08 |
| 36972857295142 - Easydrip SafeGard Duo Safety Pen Needles | 2025-07-16 |
| 36972857295142 - Easydrip SafeGard Duo Safety Pen Needles | 2025-07-16 |
| 36972857294732 - Easydrip Plus Pen Needles | 2025-05-26 |
| 36972857294749 - Easydrip Plus Pen Needles | 2025-05-26 |
| 36972857294329 - Easydrip Pen Needles | 2025-03-10 |
| 36972857293858 - Easydrip Plus Pen Needles 32G×4mm | 2024-11-19 |
| 36972857293841 - SOL-M Pen Needles 32G×4mm | 2024-11-13 |
| 36972857293605 - Easydrip ReadyGard Duo Safety Pen Needles 31G×5mm | 2024-10-24 |
| 36972857293612 - Easydrip ReadyGard Safety Pen Needles 30G×8mm | 2024-10-24 |