| Primary Device ID | 08717213037854 |
| NIH Device Record Key | 9f06e0d5-c47e-4292-a845-4216c95f7833 |
| Commercial Distribution Discontinuation | 2019-07-17 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | selectSeed™ I-125 |
| Version Model Number | 130002CAL-01 |
| Catalog Number | 130002CAL |
| 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 | 770 300 9725 |
| info.america@elekta.com |
| Special Storage Condition, Specify | Between 0 and 0 *Storage of selectSeeds™ I-125 has to be in a place with adequate radiation protection that is safe from unauthorized access, in accordance with the regulations of radionuclide laboratories. |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08717213037854 [Primary] |
| KXK | Source, Brachytherapy, Radionuclide |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-07-17 |
| Device Publish Date | 2015-10-22 |
| 98717213037840 | Non-sterile IODINE—125 source for use with seedSelectron® for system verification. Not for h |
| 98717213037833 | Sterile IODINE—125 source for interstitial Brachytherapy for use with seedSelectron®. Quanti |
| 08717213037854 | Non-sterile IODINE—125 source for use with seedSelectron® for system calibration. Not for hu |