| Primary Device ID | 00811099014355 |
| NIH Device Record Key | ddb0ce4d-f3d0-495e-9e50-c0f974659e32 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ReNew Disposable Tenaculum Tip (10mm) |
| Version Model Number | 3422 |
| Company DUNS | 184080570 |
| Company Name | MICROLINE SURGICAL, INC. |
| Device Count | 10 |
| 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 | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00811099014355 [Unit of Use] |
| GS1 | 00811099014362 [Primary] |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-09-17 |
| Device Publish Date | 2025-09-09 |
| 00811099014331 - ReNew Disposable Tenaculum Tip (5mm) | 2025-09-17 |
| 00811099014355 - ReNew Disposable Tenaculum Tip (10mm) | 2025-09-17 |
| 00811099014355 - ReNew Disposable Tenaculum Tip (10mm) | 2025-09-17 |
| 00811099014294 - ReNew XR Handpiece with Reference Length Markings | 2024-07-12 |
| 00081109901429 - ReNew XR Handpiece with Reference Length Markings | 2024-05-13 |
| 00811099014256 - ReNew XR Handpiece with Reference Length Markings | 2024-05-13 |
| 00811099014263 - ReNew XR Handpiece with Reference Length Markings | 2024-05-13 |
| 00811099014270 - ReNew XR Handpiece with Reference Length Markings | 2024-05-13 |
| 00811099014287 - ReNew XR Handpiece with Reference Length Markings | 2024-05-13 |