| Primary Device ID | 05713513000942 |
| NIH Device Record Key | d81d557f-0a97-4102-b52a-72ab69e3781e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CALAJECT |
| Version Model Number | 2118 |
| Company DUNS | 307549241 |
| Company Name | Rønvig Dental Manufacturing A/S |
| Device Count | 1 |
| DM Exempt | false |
| 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 | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | 8662442954 |
| orders@aseptico.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05713513000942 [Primary] |
| EJI | Syringe, Cartridge |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[05713513000942]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2017-09-28 |
| 05713513000089 - CONTA-GUARD | 2022-10-06 200 pcs. of laminated disposable foil for protection against needle stick. |
| 05713513000119 - COMPO-JECT | 2022-10-06 Composite Applicator for delivery of dental materials in pre-filled unit-dose tips for direct oral application. |
| 05713513000157 - CTT CERAMIC TISSUE TRIMMER | 2022-10-06 A rotating instrument used for minor surgical procedures in dentistry. |
| 05713513000362 - CONTA-GUARD | 2022-10-06 A autoclavable Recapping Stand for one-handed handling of injection needles to avoid needle stick injuries. |
| 05713513001000 - EASE-IT | 2022-10-06 Heating Unit with electronic temperature control, 40° - 60°C / 104°- 140°F, designed for warming up dental composite materia |
| 05713513000164 - DENTO PREP | 2022-10-05 Dental Micro-blaster for use with aluminium oxide powder. |
| 05713513000010 - ASPIJECT | 2018-11-22 Self-aspirating dental injection syringe for 1.8 ml standard dental cartridges |
| 05713513000058 - PAROJECT | 2018-07-06 Intraligamental injection syringe |