| Primary Device ID | 28809407787097 |
| NIH Device Record Key | 091c8a3f-1029-40ea-862d-3aafe2e48484 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Miracu FCL BI 18Gx100mm |
| Version Model Number | L-FTN1811G |
| Company DUNS | 688432407 |
| Company Name | Feeltech Co.,Ltd. |
| Device Count | 10 |
| 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 | false |
| Manufacturing Date | false |
| 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 | 08809407787093 [Unit of Use] |
| GS1 | 18809407787090 [Primary] |
| GS1 | 28809407787097 [Package] Contains: 18809407787090 Package: INBOX [10 Units] In Commercial Distribution |
| GS1 | 38809407787094 [Package] Package: CARTONBOX [300 Units] In Commercial Distribution |
| NEW | Suture, Surgical, Absorbable, Polydioxanone |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-03-05 |
| Device Publish Date | 2020-02-26 |