| Primary Device ID | 03701398102709 |
| NIH Device Record Key | c834ad51-1ee7-464b-b10f-a41321c010be |
| Commercial Distribution Discontinuation | 2022-09-30 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Ultra Safety Plus Twist kit 25G Long |
| Version Model Number | 01N4552 |
| Company DUNS | 275273795 |
| Company Name | SEPTODONT SAS SPECIALITES SEPTODONT |
| Device Count | 101 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| 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 |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03701398102709 [Direct Marking] |
| GS1 | 03701398103232 [Primary] |
| GS1 | 03701398105281 [Primary] |
| GS1 | 03701398105298 [Primary] |
| GS1 | 03701398105304 [Primary] |
| GS1 | 03701398105311 [Primary] |
| GS1 | 03701398105328 [Primary] |
| EJI | Syringe, Cartridge |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[03701398102709]
Moist Heat or Steam Sterilization
[03701398102709]
Moist Heat or Steam Sterilization
[03701398102709]
Moist Heat or Steam Sterilization
[03701398102709]
Moist Heat or Steam Sterilization
[03701398102709]
Moist Heat or Steam Sterilization
[03701398102709]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-10-10 |
| Device Publish Date | 2022-09-30 |
| 03760140703335 - BIODENTINE | 2023-06-13 Bioactive dentin substitute |
| 03760140703366 - BIODENTINE - 5 PACK | 2023-06-13 Bioactive dentin substitute |
| 03701398102709 - Ultra Safety Plus Twist kit 25G Long | 2022-10-10100 needles 25G long (Red) and 1 handle (to be sterilized) |
| 03701398102709 - Ultra Safety Plus Twist kit 25G Long | 2022-10-10 100 needles 25G long (Red) and 1 handle (to be sterilized) |
| 03701398101986 - Biodentine XP 200 | 2022-02-15 Bioactive dentin substitute |
| 03701398101993 - Biodentine XP 500 | 2022-02-15 Bioactive dentin substitute |
| 03701398102556 - BioRoot Flow- 2 g | 2022-02-09 Bioactive mineral Root Canal Sealer |
| 03701398102563 - BioRoot Flow-0.5 g | 2022-02-09 Bioactive mineral Root Canal Sealer |
| 33760140704371 - Endosolv | 2021-01-14 solvent for endodontic cements |