| Primary Device ID | 04710961935674 |
| NIH Device Record Key | 3648b9cd-76ed-47dd-b1b8-501aa44c6b8d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Silicone Round Drain |
| Version Model Number | 2015-0308 |
| Company DUNS | 656763489 |
| Company Name | FORTUNE MEDICAL INSTRUMENT CORP. |
| Device Count | 10 |
| 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 | 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 | 04710961935674 [Unit of Use] |
| GS1 | 14710961935671 [Primary] |
| GCD | Connector, Catheter |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-01-17 |
| Device Publish Date | 2022-01-07 |
| 04711182607395 | 2015-0314 |
| 04711182607388 | 2015-0312 |
| 04711182607371 | 2015-0212 |
| 04710961935711 | 2015-0320 |
| 04710961935704 | 2015-0318 |
| 04710961935698 | 2015-0316 |
| 04710961935681 | 2015-0310 |
| 04710961935674 | 2015-0308 |
| 04710961935605 | 2015-0220 |
| 04710961935599 | 2015-0218 |
| 04710961935582 | 2015-0216 |
| 04710961935575 | 2015-0214 |
| 04710961935568 | 2015-0210 |
| 04710961935551 | 2015-0208 |