| Primary Device ID | 14582233916226 |
| NIH Device Record Key | f5878091-05de-494d-a518-4ee1333aae1d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | F-18 Floppy |
| Version Model Number | F18P06ST300 |
| Company DUNS | 696947837 |
| Company Name | FMD CO., LTD. |
| Device Count | 1 |
| 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 | true |
| OTC Over-The-Counter | false |
| Length | 300 Centimeter |
| Outer Diameter | 0.018 Inch |
| Length | 300 Centimeter |
| Outer Diameter | 0.018 Inch |
| Length | 300 Centimeter |
| Outer Diameter | 0.018 Inch |
| Length | 300 Centimeter |
| Outer Diameter | 0.018 Inch |
| Length | 300 Centimeter |
| Outer Diameter | 0.018 Inch |
| Length | 300 Centimeter |
| Outer Diameter | 0.018 Inch |
| Length | 300 Centimeter |
| Outer Diameter | 0.018 Inch |
| Length | 300 Centimeter |
| Outer Diameter | 0.018 Inch |
| Length | 300 Centimeter |
| Outer Diameter | 0.018 Inch |
| Length | 300 Centimeter |
| Outer Diameter | 0.018 Inch |
| Length | 300 Centimeter |
| Outer Diameter | 0.018 Inch |
| Length | 300 Centimeter |
| Outer Diameter | 0.018 Inch |
| Length | 300 Centimeter |
| Outer Diameter | 0.018 Inch |
| Length | 300 Centimeter |
| Outer Diameter | 0.018 Inch |
| Length | 300 Centimeter |
| Outer Diameter | 0.018 Inch |
| Length | 300 Centimeter |
| Outer Diameter | 0.018 Inch |
| Length | 300 Centimeter |
| Outer Diameter | 0.018 Inch |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04582233916229 [Primary] |
| GS1 | 14582233916226 [Package] Contains: 04582233916229 Package: [5 Units] In Commercial Distribution |
| DQX | Wire, Guide, Catheter |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-08-28 |
| Device Publish Date | 2024-08-20 |
| 14582233916226 | Guidewire |
| 14582233916219 | Guidewire |