| Primary Device ID | 18809327350664 |
| NIH Device Record Key | 83f74257-dc94-44d9-968b-2093b61eb7ff |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Clear-Jet Injection Catheter |
| Version Model Number | FM-EI0002(I2)(2300)(0.1T) |
| 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 |
| Phone | +82537418388 |
| finemedix@finemedix.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08809327350667 [Primary] |
| GS1 | 18809327350664 [Package] Contains: 08809327350667 Package: Box [10 Units] In Commercial Distribution |
| FBK | Endoscopic Injection Needle, Gastroenterology-Urology |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-04-22 |
| Device Publish Date | 2019-04-12 |
| 08809327352432 | 23G-6mm/ 0.1T/ 2,300mm |
| 18809327352422 | 23G-4mm/ 0.08T/ 2,300mm/ Non-head |
| 18809327352415 | 23G-4mm/ 0.1T/ 1,800mm |
| 18809327352408 | 23G-4mm/ 0.05T/ 1,800mm |
| 18809327352392 | 23G-4mm/ 0.1T/ 2,300mm |
| 18809327352385 | 23G-4mm/ 0.05T/ 2,300mm |
| 08809327351084 | 23G-6mm/ 0.05T/ 2,300mm |
| 18809327350671 | 23G-4mm/ 0.05T/ 2,300mm/ Non-head |
| 18809327350664 | 23G-4mm/ 0.1T/ 2,300mm/ Non-head |