| Primary Device ID | B1657001327022825052 |
| NIH Device Record Key | 24bdb863-7435-46eb-81ee-1f6509495ece |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Smit Sleeve 20mm |
| Version Model Number | 7001 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B1657001327022825052 [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 | 2025-04-10 |
| Device Publish Date | 2025-04-02 |
| B16556500327022824146 - Small Prostate Template | 2025-04-10 small prostate template |
| B16556510327033125011 - Medium Prostate Template | 2025-04-10 medium prostate template |
| B16557060327033125016 - Flexi-Needle | 2025-04-10 Flexible brachytherapy needle, 15ga, 30cm, stainless steel obturator, 5 per pack |
| B16557640327033125040 - Flexi-Needle | 2025-04-10 Flexible brachytherapy needle, 15ga, 25cm, w/ female luer, stainless steel obturator, 1 per pack |
| B16557650327033125039 - Flexi-Needle | 2025-04-10 Flexible brachytherapy needle, 15ga, 25cm, w/ female luer, stainless steel obturator, 5 per pack |
| B16558000326113024188 - Small Prostate Brachytherapy Kit | 2025-04-10 The prostate brachytherapy kit provides the prostate template and flexineedles used in prostate brachytherapy |
| B16559070327033125009 - Buttons | 2025-04-10 Button, 15ga, radiopaque, 5 per pack, yellow |
| B16559100327022824119 - Buttons | 2025-04-10 Button, 15ga, radiopaque, 5 per pack, multicolor |