| Primary Device ID | 18809327352835 |
| NIH Device Record Key | 1dd47e3b-86b8-4e91-82a5-29b3e5743a0b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ClearCap Distal Attachment |
| Version Model Number | FM-EC0004 |
| Company DUNS | 688256864 |
| Company Name | FINEMEDIX CO.,LTD. |
| 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 | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08809327352838 [Primary] |
| GS1 | 18809327352835 [Package] Contains: 08809327352838 Package: Box [10 Units] In Commercial Distribution |
| GS1 | 28809327352832 [Package] Contains: 08809327352838 Package: Box [50 Units] In Commercial Distribution |
| OCX | Endoscopic Irrigation/Suction System |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-03-19 |
| Device Publish Date | 2021-03-11 |
| 18809327352859 | 14mm/11.6mm |
| 18809327352842 | 13.4mm/11mm |
| 18809327352835 | 12.4mm/10mm |
| 18809327352828 | 11.35mm/8.9mm |
| 18809327352811 | 11.8mm/9.4mm |
| 18809327352804 | 15mm/12.6mm |
| 18809327350633 | 15.7mm/13.3mm |