| Primary Device ID | 08717213030473 |
| NIH Device Record Key | 81f7d261-6442-441d-9435-02d3afdd8313 |
| Commercial Distribution Discontinuation | 2019-07-17 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Version Model Number | 130025-06 |
| Company DUNS | 415269930 |
| Company Name | Nucletron B.V. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 |
| Phone | +1(770)300-9725 |
| info.america@elekta.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08717213023956 [Primary] |
| GS1 | 08717213030473 [Package] Contains: 08717213023956 Package: [8 Units] Discontinued: 2019-07-17 Not in Commercial Distribution |
| JAQ | System, applicator, radionuclide, remote-controlled |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-07-17 |
| Device Publish Date | 2016-09-23 |
| 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 |