| Primary Device ID | 36972857293025 |
| NIH Device Record Key | fb1d42ae-bb4c-496e-a534-5937ad82c64a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EasyDrip ReadyGard Duo Safety Pen Needles 30G 6mm |
| Version Model Number | 05-3006 |
| 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 | true |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06972857293024 [Unit of Use] |
| GS1 | 16972857293021 [Primary] |
| GS1 | 36972857293025 [Package] Contains: 16972857293021 Package: [8 Units] 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 | 2024-01-23 |
| Device Publish Date | 2024-01-15 |
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| 36972857293841 - SOL-M Pen Needles 32G×4mm | 2024-11-13 |