| Primary Device ID | 00850078230263 |
| NIH Device Record Key | 2417abe3-eead-43f6-9d3d-7e1ce5ec9971 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Mahe Medical USA |
| Version Model Number | U-ESR-KS5-AO-S |
| Company DUNS | 044831540 |
| Company Name | MAHE MEDICAL USA LLC |
| 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 | true |
| 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 |
| Phone | 8556243633 |
| keith@mahemedical.com | |
| Phone | 8556243633 |
| keith@mahemedical.com | |
| Phone | 8556243633 |
| keith@mahemedical.com | |
| Phone | 8556243633 |
| keith@mahemedical.com | |
| Phone | 8556243633 |
| keith@mahemedical.com | |
| Phone | 8556243633 |
| keith@mahemedical.com | |
| Phone | 8556243633 |
| keith@mahemedical.com | |
| Phone | 8556243633 |
| keith@mahemedical.com | |
| Phone | 8556243633 |
| keith@mahemedical.com | |
| Phone | 8556243633 |
| keith@mahemedical.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850078230263 [Primary] |
| HWB | Extractor |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-09-22 |
| Device Publish Date | 2025-09-12 |
| 00850078230157 | Retractor Muller Type |
| 00850078230140 | Ranawat Retractor Right |
| 00850078230133 | Ranawat Retractor Left |
| 00085007823012 | Mios Modified Hohmann Lever Curved Retractor |
| 00850078230270 | Fully assembled and sterilized Single Pack Stripped Screw 6.0mm-7.5mm |
| 00850078230263 | Fully assembled and sterilized Single Pack Stripped Screw 5.5mm-6.5mm |
| 00850078230256 | Fully assembled and sterilized Single Pack Stripped Screw 4.5mm-5.5mm |
| 00850078230249 | Fully assembled and sterilized Single Pack Stripped Screw 3.5mm-4.5mm |
| 00850078230232 | Fully assembled and sterilized Single Pack Stripped Screw 2.5mm-3.5mm |
| 00850078230225 | Fully assembled and sterilized Single Pack Stripped Screw 2.0mm-2.5mm |
| 00850078230218 | Fully assembled and sterilized Single Pack Broken Screw 6.0mm-7.5mm |
| 00850078230201 | Fully assembled and sterilized Single Pack Broken Screw 5.5mm-6.5mm |
| 00850078230195 | Fully assembled and sterilized Single Pack Broken Screw 4.5mm-5.5mm |
| 00850078230188 | Fully assembled and sterilized Single Pack Broken Screw 3.5mm-4.5mm |
| 00850078230171 | Fully assembled and sterilized Single Pack Broken Screw 2.5mm-3.5mm |
| 00850078230164 | Fully assembled and sterilized Single Pack Broken Screw 2.0mm-2.5mm |