| Primary Device ID | 00812444027310 |
| NIH Device Record Key | 8a0988cb-59b5-4e6d-ac26-40e0613f8953 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Applicator Needle |
| Version Model Number | 1100-1812X |
| Company DUNS | 964053560 |
| Company Name | RIVERPOINT MEDICAL, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | true |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00812444027310 [Primary] |
| GS1 | 10812444027317 [Package] Package: [5 Units] In Commercial Distribution |
| GS1 | 20812444027314 [Package] Package: [10 Units] In Commercial Distribution |
| KXK | Source, Brachytherapy, Radionuclide |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-05-24 |
| Device Publish Date | 2017-11-02 |
| 10810020085225 - HS Fiber | 2024-08-15 Suture Tape |
| 10810020083672 - HS Fiber | 2024-08-08 Suture |
| 00840277404756 - Iconix | 2024-08-05 Iconix Knotless, 1.4mm Anchor with XBraid™ S (Blue/Black/White) |
| 00840277404763 - Iconix | 2024-08-05 Iconix Knotless, 2.3mm Anchor with #2 XBraid S (Blue/Black) |
| 10812444029441 - HS FIber | 2024-06-26 Suture Tape |
| 00810020080285 - OrthoButton CL | 2024-05-24 Continuous Loop with Titanium Button |
| 00810020080292 - OrthoButton CL | 2024-05-24 Continuous Loop with Titanium Button |
| 00810020080308 - OrthoButton CL | 2024-05-24 Continuous Loop with Titanium Button |