| Primary Device ID | 06972857293581 |
| NIH Device Record Key | bf4df506-668f-48aa-b3df-f3be02747f9e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Easydrip ReadyGard Safety Pen Needles 30G×5mm |
| Version Model Number | HE 06-3005 |
| 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 | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06972857293581 [Unit of Use] |
| GS1 | 16972857293588 [Primary] |
| 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 | 2024-10-21 |
| Device Publish Date | 2024-10-11 |
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| 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 |
| 36972857293575 - Easydrip ReadyGard Duo Safety Pen Needles 30G×5mm | 2024-10-21 |
| 06972857293581 - Easydrip ReadyGard Safety Pen Needles 30G×5mm | 2024-10-21 |
| 06972857293581 - Easydrip ReadyGard Safety Pen Needles 30G×5mm | 2024-10-21 |
| 36972857293599 - Easydrip ReadyGard Safety Pen Needles 31G×8mm | 2024-10-21 |
| 36972857293346 - Easydrip ReadyGard Duo Safety Pen Needles 31G×5mm | 2024-08-09 |