Primary Device ID | 07640142415435 |
NIH Device Record Key | fd806eab-9c65-4f67-9dad-48c250f14916 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | H-FILES |
Version Model Number | 01.153.31.055.CG |
Catalog Number | 01.153.31.055.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 | 07640142415435 [Primary] |
EKS | File, Pulp Canal, Endodontic |
Steralize Prior To Use | true |
Device Is Sterile | false |
[07640142415435]
Moist Heat or Steam Sterilization
[07640142415435]
Moist Heat or Steam Sterilization
[07640142415435]
Moist Heat or Steam Sterilization
[07640142415435]
Moist Heat or Steam Sterilization
[07640142415435]
Moist Heat or Steam Sterilization
[07640142415435]
Moist Heat or Steam Sterilization
[07640142415435]
Moist Heat or Steam Sterilization
[07640142415435]
Moist Heat or Steam Sterilization
[07640142415435]
Moist Heat or Steam Sterilization
[07640142415435]
Moist Heat or Steam Sterilization
[07640142415435]
Moist Heat or Steam Sterilization
[07640142415435]
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 |