| 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 |
| B16556620327043024147 - Intrauterine Tandem | 2025-05-13 Intrauterine tandem, 6mm OD, graduated |
| B16558000326113025071 - Small Prostate Brachytherapy Kit | 2025-05-13 The prostate brachytherapy kit provides the prostate template and flexineedles used in prostate brachytherapy |
| B16558010326123125031 - Medium Prostate Brachytherapy Kit | 2025-05-13 The prostate brachytherapy kit provides the prostate template and flexineedles used in prostate brachytherapy |
| B16559050327043025021 - Buttons | 2025-05-13 Button, 15ga, radiopaque, 5 per pack, green |
| B16559080327043025008 - Buttons | 2025-05-13 Button, 15ga, radiopaque, 5 per pack, purple |
| B16570940327043025081 - Adapter | 2025-05-13 Adapter flexineedle 15ga 60mm non sterile |
| B16557650327043025078 - Flexi-Needle | 2025-05-09 Flexible brachytherapy needle, 15ga, 25cm, w/ female luer, stainless steel obturator, 5 per pack |
| B16556500327022824146 - Small Prostate Template | 2025-04-10 small prostate template |