| Primary Device ID | B136MLB300MR0 |
| NIH Device Record Key | e33370d0-d9cc-499a-b40c-b4cd2e14fb7d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Sun Nuclear MICRO+ MR |
| Version Model Number | MLB+300MR |
| Catalog Number | 805898 |
| Company DUNS | 157308230 |
| Company Name | GAMMEX, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | MR Conditional |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| 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 | B136MLB300MR0 [Primary] |
| IWE | Monitor, Patient Position, Light-Beam |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-02-02 |
| Device Publish Date | 2021-01-25 |
| B136MLR350MR0 | The MICRO+ MR MLR+350 Laser is used for aligning patients to medical diagnostic imaging and radi |
| B136MLR300MR0 | The MICRO+ MR MLR+300 Laser is used for aligning patients to medical diagnostic imaging and radi |
| B136MLG350MR0 | The MICRO+ MR MLG+350 Laser is used for aligning patients to medical diagnostic imaging and radi |
| B136MLG300MR0 | The MICRO+ MR MLB+350 Laser is used for aligning patients to medical diagnostic imaging and radi |
| B136MLB350MR0 | The MICRO+ MR MLB+350 Laser is used for aligning patients to medical diagnostic imaging and radi |
| B136MLB300MR0 | MLB+300MR |