| Primary Device ID | 57340007000480 |
| NIH Device Record Key | 3372b3fe-977e-4dde-950e-f67365850eeb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MR Stylet |
| Version Model Number | 4013-06 |
| Company DUNS | 774856749 |
| Company Name | Clinical Laserthermia Systems AB |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | MR Safe |
| 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 |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 17340007000482 [Primary] |
| GS1 | 37340007000486 [Package] Contains: 17340007000482 Package: [5 Units] In Commercial Distribution |
| GS1 | 57340007000480 [Package] Contains: 17340007000482 Package: [10 Units] In Commercial Distribution |
| GAH | Stylet, Surgical, General & Plastic Surgery |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-12-06 |
| 57340007000480 | 4013-06 |
| 37340007000608 | 4013-13 |
| 37340007000585 | 4013-11 |
| 37340007000561 | 4013-08 |