| Primary Device ID | 07640142414964 |
| NIH Device Record Key | 7f3a4999-f870-42fb-84f8-0af3d7c7a7c8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | H-FILES |
| Version Model Number | 01.153.21.050.CG |
| Catalog Number | 01.153.21.050.CG |
| Company DUNS | 482884061 |
| Company Name | FKG Dentaire Sàrl |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07640142414964 [Primary] |
| EKS | File, Pulp Canal, Endodontic |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[07640142414964]
Moist Heat or Steam Sterilization
[07640142414964]
Moist Heat or Steam Sterilization
[07640142414964]
Moist Heat or Steam Sterilization
[07640142414964]
Moist Heat or Steam Sterilization
[07640142414964]
Moist Heat or Steam Sterilization
[07640142414964]
Moist Heat or Steam Sterilization
[07640142414964]
Moist Heat or Steam Sterilization
[07640142414964]
Moist Heat or Steam Sterilization
[07640142414964]
Moist Heat or Steam Sterilization
[07640142414964]
Moist Heat or Steam Sterilization
[07640142414964]
Moist Heat or Steam Sterilization
[07640142414964]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-08-22 |
| Device Publish Date | 2022-08-14 |
| 07640142415503 | H-Files 153, 31 mm, # 45-80, handle SMG |
| 07640142415497 | H-Files 153, 31 mm, # 15-40, handle SMG |
| 07640142415466 | H-Files 153, 31 mm, # 80, handle SMG |
| 07640142415459 | H-Files 153, 31 mm, # 70, handle SMG |
| 07640142415442 | H-Files 153, 31 mm, # 60, handle SMG |
| 07640142415435 | H-Files 153, 31 mm, # 55, handle SMG |
| 07640142415428 | H-Files 153, 31 mm, # 50, handle SMG |
| 07640142415411 | H-Files 153, 31 mm, # 45, handle SMG |
| 07640142415404 | H-Files 153, 31 mm, # 40, handle SMG |
| 07640142415398 | H-Files 153, 31 mm, # 35, handle SMG |
| 07640142415381 | H-Files 153, 31 mm, # 30, handle SMG |
| 07640142415374 | H-Files 153, 31 mm, # 25, handle SMG |
| 07640142415367 | H-Files 153, 31 mm, # 20, handle SMG |
| 07640142415350 | H-Files 153, 31 mm, # 15, handle SMG |
| 07640142415343 | H-Files 153, 31 mm, # 10, handle SMG |
| 07640142415336 | H-Files 153, 31 mm, # 8, handle SMG |
| 07640142415312 | H-Files 153, 25 mm, # 45-80, handle SMG |
| 07640142415299 | H-Files 153, 25 mm, # 15-40, handle SMG |
| 07640142415275 | H-Files 153, 25 mm, # 80, handle SMG |
| 07640142415268 | H-Files 153, 25 mm, # 70, handle SMG |
| 07640142415251 | H-Files 153, 25 mm, # 60, handle SMG |
| 07640142415237 | H-Files 153, 25 mm, # 55, handle SMG |
| 07640142415220 | H-Files 153, 25 mm, # 50, handle SMG |
| 07640142415213 | H-Files 153, 25 mm, # 45, handle SMG |
| 07640142415190 | H-Files 153, 25 mm, # 40, handle SMG |
| 07640142415176 | H-Files 153, 25 mm, # 35, handle SMG |
| 07640142415152 | H-Files 153, 25 mm, # 30, handle SMG |
| 07640142415138 | H-Files 153, 25 mm, # 25, handle SMG |
| 07640142415114 | H-Files 153, 25 mm, # 20, handle SMG |
| 07640142415091 | H-Files 153, 25 mm, # 15, handle SMG |
| 07640142415077 | H-Files 153, 25 mm, # 10, handle SMG |
| 07640142415053 | H-Files 153, 25 mm, # 8, handle SMG |
| 07640142415046 | H-Files 153, 21 mm, # 45-80, handle SMG |
| 07640142415022 | H-Files 153, 21 mm, # 15-40, handle SMG |
| 07640142415008 | H-Files 153, 21 mm, # 80, handle SMG |
| 07640142414995 | H-Files 153, 21 mm, # 70, handle SMG |
| 07640142414988 | H-Files 153, 21 mm, # 60, handle SMG |
| 07640142414971 | H-Files 153, 21 mm, # 55, handle SMG |
| 07640142414964 | H-Files 153, 21 mm, # 50, handle SMG |
| 07640142414940 | H-Files 153, 21 mm, # 45, handle SMG |
| 07640142414926 | H-Files 153, 21 mm, # 40, handle SMG |
| 07640142414902 | H-Files 153, 21 mm, # 35, handle SMG |
| 07640142414889 | H-Files 153, 21 mm, # 30, handle SMG |
| 07640142414865 | H-Files 153, 21 mm, # 25, handle SMG |
| 07640142414841 | H-Files 153, 21 mm, # 20, handle SMG |
| 07640142414827 | H-Files 153, 21 mm, # 15, handle SMG |
| 07640142414803 | H-Files 153, 21 mm, # 10, handle SMG |
| 07640142414513 | H-Files 153, 21 mm, # 8, handle SMG |