| Primary Device ID | 18809327352569 |
| NIH Device Record Key | e3a14383-26cc-42c1-b35c-f55ef9d66ba6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Clear-Bite Biopsy Forceps |
| Version Model Number | FM-EF0002 |
| Company DUNS | 688256864 |
| Company Name | FINEMEDIX CO.,LTD. |
| 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 | 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 | 08809327352562 [Primary] |
| GS1 | 18809327352569 [Package] Contains: 08809327352562 Package: Box [20 Units] In Commercial Distribution |
| FCL | Forceps, Biopsy, Non-Electric |
| 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 |
| 18809327352651 | Φ2.3/ 2,300mm/ Round/ Coated |
| 08809327352647 | Φ2.3/ 2,300mm/ Needle |
| 18809327352620 | Φ2.3/ 2,400mm/ Oval |
| 18809327352613 | Φ2.3/ 1,600mm/ Round/ Coated |
| 18809327352583 | Φ2.3/ 1,600mm/ Oval |
| 18809327352569 | Φ1.72/ 2,400mm/ Oval |
| 18809327352545 | Φ1.72/ 1,600mm/ Oval |