| Primary Device ID | B16556550323093024039 |
| NIH Device Record Key | 81384f34-2655-4070-91b8-4d3f2c814109 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Brachytherapy Kit |
| Version Model Number | 5655 |
| 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 |
| 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 | B16556550323093024039 [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 | 2024-04-23 |
| Device Publish Date | 2024-04-15 |
| B16556550323093024039 | (1) 5653- 15ga, 30cm catheter w/button. 5/pk (1) 5654- 17ga, 20cm implant needles w/stylet, 5/pk |
| B16556420326033124044 | (1) 5641- 15ga, 30cm catheter w/button. 5/pk (1) 5621- 17ga, 20cm implant needles w/stylet, 5/pk |