| Primary Device ID | 28800145524401 |
| NIH Device Record Key | 1f961670-021e-425a-9e3b-5c7c77b5d79e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Miracu MONO 27Gx50mm FDA |
| Version Model Number | 27055B |
| Company DUNS | 688432407 |
| Company Name | Feeltech Co.,Ltd. |
| Device Count | 25 |
| 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 | true |
| 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 | 08800145524407 [Unit of Use] |
| GS1 | 18800145524404 [Primary] |
| GS1 | 28800145524401 [Package] Contains: 18800145524404 Package: INBOX [100 Units] In Commercial Distribution |
| GS1 | 38800145524408 [Package] Package: CARTON BOX [1000 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 | 2026-03-06 |
| Device Publish Date | 2026-02-26 |
| 28800145524197 - Miracu FCL FORTE 18Gx100mm | 2026-03-06 |
| 28800145524203 - Miracu FCL FORTE 19Gx70mm | 2026-03-06 |
| 28800145524210 - Miracu FCL FORTE 19Gx100mm | 2026-03-06 |
| 28800145524265 - Miracu FCL FORTE FIX 18Gx100mm | 2026-03-06 |
| 28800145524272 - Miracu FCL FORTE FIX 19Gx70mm | 2026-03-06 |
| 28800145524302 - Miracu FCV Line 17Gx70mm | 2026-03-06 |
| 28800145524319 - iracu FCV Line 17Gx100mm | 2026-03-06 |
| 28800145524395 - Miracu MONO 27Gx40mm FDA | 2026-03-06 |