| Primary Device ID | 00860008449801 |
| NIH Device Record Key | fb6ad192-fe26-42c3-91d8-0875e8949c2e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SpiraLith Ca |
| Version Model Number | Rx-2903C |
| Company DUNS | 042903703 |
| Company Name | Micropore, Inc. |
| Device Count | 1 |
| 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 | true |
| 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 | 00860008449801 [Package] Contains: 00860008449825 Package: [9 Units] In Commercial Distribution |
| GS1 | 00860008449825 [Primary] |
| CBL | Absorbent, Carbon-Dioxide |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-06-06 |
| Device Publish Date | 2024-05-29 |
| 00860008449849 | Rx-3903C |
| 10860008449839 | Rx-3719C |
| 00860008449801 | Rx-2903C |
| 10860008449877 | Rx-3616C |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SPIRALITH CA 87734129 5594013 Live/Registered |
Micropore, Inc. 2017-12-26 |