| Primary Device ID | B16558020326063024190 |
| NIH Device Record Key | e57c91e9-0ad1-4b8a-b262-9baca87abc70 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Large Prostate Brachytherapy Kit |
| Version Model Number | 5802 |
| Company DUNS | 967592978 |
| Company Name | Liberty Medical , Inc. |
| 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 | 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 |
| Needle Gauge | 15 Gauge |
| Needle Gauge | 15 Gauge |
| Needle Gauge | 15 Gauge |
| Needle Gauge | 15 Gauge |
| Needle Gauge | 15 Gauge |
| Needle Gauge | 15 Gauge |
| Needle Gauge | 15 Gauge |
| Needle Gauge | 15 Gauge |
| Needle Gauge | 15 Gauge |
| Needle Gauge | 15 Gauge |
| Needle Gauge | 15 Gauge |
| Needle Gauge | 15 Gauge |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B16558020326063024190 [Primary] |
| IWJ | System, Applicator, Radionuclide, Manual |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-08-11 |
| Device Publish Date | 2025-08-01 |
| B16558020325083123195 | The prostate brachytherapy kit provides the prostate template and flexineedles used in prostate |
| B16558020325123124041 | The prostate brachytherapy kit provides the prostate template and flexineedles used in prostate |
| B16558020325123124069 | The prostate brachytherapy kit provides the prostate template and flexineedles used in prostate |
| B16558020326063024101 | The prostate brachytherapy kit provides the prostate template and flexineedles used in prostate |
| B16558020326063024190 | The prostate brachytherapy kit provides the prostate template and flexineedles used in prostate |