| Primary Device ID | 28809407788438 |
| NIH Device Record Key | 668c820e-da0f-4d34-b7bc-711ca90b922e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AMI Custom Crafted FCL | 18G x 100mm |
| 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 | 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 | 08809407788434 [Unit of Use] |
| GS1 | 18809407788431 [Primary] |
| GS1 | 28809407788438 [Package] Contains: 18809407788431 Package: INBOX [10 Units] In Commercial Distribution |
| GS1 | 38809407788435 [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 | 2021-03-01 |
| Device Publish Date | 2021-02-19 |