| Primary Device ID | 10818392018452 |
| NIH Device Record Key | 1594019c-d593-4c4f-b506-7d856bb9cb50 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SOL-CARE Safety Needle |
| Version Model Number | PSN1815 |
| Company DUNS | 069590113 |
| Company Name | SOL-MILLENNIUM MEDICAL INC |
| Device Count | 1 |
| 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 | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(404)973-2200 |
| SOLMCHUinform@sol-m.com |
| Needle Gauge | 18 Gauge |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00818392018455 [Primary] |
| GS1 | 10818392018452 [Package] Contains: 00818392018455 Package: Box [100 Units] In Commercial Distribution |
| GS1 | 20818392018459 [Package] Package: Case [8 Units] In Commercial Distribution |
| FMI | Needle, hypodermic, single lumen |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-10-23 |
| Device Publish Date | 2019-04-10 |
| 10818392018728 | SOL-CARE Safety Needle 27Gx1/2 |
| 20818392018671 | SOL-CARE Safety Needle 25Gx1 |
| 20818392018664 | SOL-CARE Safety Needle 25Gx5/8 |
| 10818392018629 | SOL-CARE Safety Needle 23Gx1 |
| 10818392018568 | SOL-CARE Safety Needle 25Gx1 1/2 |
| 10818392018537 | SOL-CARE Safety Needle 22Gx1 1/2 |
| 10818392018452 | SOL-CARE Safety Needle 18Gx1 1/2 |
| 20818392018749 | SOL-CARE Safety Needle 30Gx1/2 |
| 10818392018612 | SOL-CARE Safety Needle 22Gx1 |
| 20818392018596 | SOL-CARE Safety Needle 21Gx1 |