| Primary Device ID | 08717213013902 |
| NIH Device Record Key | 08f5afb4-89d7-4018-81ce-be75d142b244 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 101004-06 |
| Company DUNS | 415269930 |
| Company Name | Nucletron B.V. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Safe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| 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 | +1(770)300-9725 |
| info.america@elekta.com |
| Length | 60 Millimeter |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08717213013902 [Primary] |
| JAQ | System, applicator, radionuclide, remote-controlled |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08717213013902]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-09-30 |
| Device Publish Date | 2019-09-21 |
| 08717213057203 - Smit Sleeve | 2024-07-15 Sleeve CT/MR Intrauterine Tube |
| 08717213057258 - Smit Sleeve | 2024-07-15 Smit Sleeve CT/MR, 4mm |
| 08717213054363 - Luneray | 2022-11-23 Catheter 6F 50cm, needle 37mm R30mm |
| 08717213054370 - Luneray | 2022-11-23 Catheter 6F 50cm, needle 47mm R45mm |
| 08717213054387 - Luneray | 2022-11-23 Catheter 6F 50cm, needle 57mm R60mm |
| 08717213054394 - Luneray | 2022-11-15 Catheter 6F 50cm, needle 67mm R75mm |
| 08717213057760 - Esteya | 2022-08-24 Esteya |
| 08717213056947 - NA | 2022-07-08 INSERTION TOOL |