| Primary Device ID | 09120074395411 |
| NIH Device Record Key | ab367aa9-c071-45b8-b106-9ff597b8efa9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BreastSTEP Long Mask Basic Module |
| Version Model Number | P10107-541 |
| Company DUNS | 300005408 |
| Company Name | IT-V Medizintechnik GmbH |
| 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 | false |
| Lot Batch | true |
| Serial Number | false |
| 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 |
|---|---|
| GS1 | 09120074395411 [Primary] |
| IYE | Accelerator, Linear, Medical |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-11-20 |
| Device Publish Date | 2024-11-12 |
| 09120074394018 - HeadSTEP IMRT MR Basic Module | 2024-11-20 |
| 09120074395312 - WingSTEP high for Varian Baseplate | 2024-11-20 |
| 09120074395329 - WingSTEP low for Varian Baseplate | 2024-11-20 |
| 09120074395404 - BreastSTEP Short Mask Basic Module | 2024-11-20 |
| 09120074395411 - BreastSTEP Long Mask Basic Module | 2024-11-20 |
| 09120074395411 - BreastSTEP Long Mask Basic Module | 2024-11-20 |
| 09120074395428 - BreastSTEP Short MR Basic Module | 2024-11-20 |
| 09120074395435 - BreastSTEP Long MR Basic Module | 2024-11-20 |
| 09120074391000 - HeadSTEP Carbon Basic Module | 2024-11-11 |