| Primary Device ID | 28800145513719 |
| NIH Device Record Key | c30c2a89-ba8b-4e15-9c67-de55a3f230ba |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Rejubeau FCL FORTE 19G x 70mm |
| Version Model Number | 3BE19071620G |
| 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 | 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 | 08800145513715 [Unit of Use] |
| GS1 | 18800145513712 [Primary] |
| GS1 | 28800145513719 [Package] Contains: 18800145513712 Package: inbox [10 Units] In Commercial Distribution |
| GS1 | 38800145513716 [Package] Package: carton box [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 | 2024-10-24 |
| Device Publish Date | 2024-10-16 |
| 28800145513696 - Rejubeau N.Double FORTE 19G x 60mm | 2024-10-24 |
| 28800145513702 - Rejubeau FCL FORTE 18G x 100mm | 2024-10-24 |
| 28800145513719 - Rejubeau FCL FORTE 19G x 70mm | 2024-10-24 |
| 28800145513719 - Rejubeau FCL FORTE 19G x 70mm | 2024-10-24 |
| 28800145513368 - REJUBEAU FCN 4D 18G x 100mm (W-shape) | 2024-07-18 |
| 28800145513375 - REJUBEAU FCN 4D 19G x 100mm (W-shape) | 2024-07-18 |
| 28800145513382 - REJUBEAU FCN 4D 21G x 60mm (W-shape) | 2024-07-18 |
| 28800145508340 - IDryNeedle 0.25x30 | 2024-05-17 |
| 28800145508357 - IDryNeedle 0.25x40 | 2024-05-17 |