| Primary Device ID | B1655800326053124167 |
| NIH Device Record Key | 18368807-6860-475f-8c01-38827c0f38c6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Small Prostate Brachytherapy Kit |
| Version Model Number | 5800 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B1655800326053124167 [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 | 2025-01-15 |
| Device Publish Date | 2025-01-07 |
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| B16558000326113024188 | The prostate brachytherapy kit provides the prostate template and flexineedles used in prostate |
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