| Primary Device ID | B1657002327022825053 |
| NIH Device Record Key | 0528d35a-4d32-4360-9946-1e48e416a124 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Smit Sleeve 40mm |
| Version Model Number | 7002 |
| 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 | B1657002327022825053 [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 |
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| B16558110327083125189 - Medium Prostate Brachytherapy Kit-metal hub | 2025-12-09 The prostate brachytherapy kit provides the prostate template and flexineedles used in prostate brachytherapy |
| B16559070327113025175 - Buttons | 2025-12-09 Button, 15ga, radiopaque, 5 per pack, yellow |
| B16560920327113025219 - Flexi-Needle | 2025-12-09 Flexible brachytherapy needle, 16ga, 25cm, stainless steel obturator, 5 per pack |
| B16556620327073125099 - Intrauterine Tandem | 2025-09-02 Intrauterine tandem, 6mm OD, graduated |
| B16557650327073125116 - Flexi-Needle | 2025-09-02 Flexible brachytherapy needle, 15ga, 25cm, w/ female luer, stainless steel obturator, 5 per pack |
| B16559070327073125117 - Buttons | 2025-09-02 Button, 15ga, radiopaque, 5 per pack, yellow |
| B16559080327073125104 - Buttons | 2025-09-02 buttons, 15ga, radiopaque, purple 5/pack |