| Primary Device ID | 00851546007714 |
| NIH Device Record Key | eccc0496-29cc-45a8-b96e-fb8bc2d39bfa |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HDR microPSD |
| Version Model Number | PSD-HB5N |
| Catalog Number | PSD-HB5N |
| Company DUNS | 005744772 |
| Company Name | RADIADYNE, L.L.C. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 281-759-9600 |
| sabrinamartilla@radiadyne.com | |
| Phone | 281-759-9600 |
| sabrinamartilla@radiadyne.com | |
| Phone | 281-759-9600 |
| sabrinamartilla@radiadyne.com | |
| Phone | 281-759-9600 |
| sabrinamartilla@radiadyne.com | |
| Phone | 281-759-9600 |
| sabrinamartilla@radiadyne.com | |
| Phone | 281-759-9600 |
| sabrinamartilla@radiadyne.com | |
| Phone | 281-759-9600 |
| sabrinamartilla@radiadyne.com | |
| Phone | 281-759-9600 |
| sabrinamartilla@radiadyne.com | |
| Phone | 281-759-9600 |
| sabrinamartilla@radiadyne.com | |
| Phone | 281-759-9600 |
| sabrinamartilla@radiadyne.com | |
| Phone | 281-759-9600 |
| sabrinamartilla@radiadyne.com | |
| Phone | 281-759-9600 |
| sabrinamartilla@radiadyne.com | |
| Phone | 281-759-9600 |
| sabrinamartilla@radiadyne.com | |
| Phone | 281-759-9600 |
| sabrinamartilla@radiadyne.com | |
| Phone | 281-759-9600 |
| sabrinamartilla@radiadyne.com | |
| Phone | 281-759-9600 |
| sabrinamartilla@radiadyne.com | |
| Phone | 281-759-9600 |
| sabrinamartilla@radiadyne.com | |
| Phone | 281-759-9600 |
| sabrinamartilla@radiadyne.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00851546007714 [Primary] |
| GS1 | 10851546007728 [Package] Package: Shelf Box [4 Units] In Commercial Distribution |
| GS1 | 20851546007732 [Package] Contains: 10851546007728 Package: Shipper Box [32 Units] In Commercial Distribution |
| NZT | Dosimeter, Ionizing Radiation, Implanted |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-06-08 |
| Device Publish Date | 2018-05-08 |
| 20851546007091 - IsoLoc | 2020-01-28 IsoLoc Short Profile Prostate Immobilization Treatment Balloon Device Kit |
| 00851546007196 - OARtrac | 2019-07-11 OARtrac Plus Clinical Detector Unit (CDU) |
| 20851546007169 - QC microPSD | 2019-06-14 QC microPSD sensor cable |
| 20851546007619 - Electron microPSD | 2019-05-30 Electron non-sterile microPSD sensor cable |
| 20851546007107 - IsoLoc | 2018-07-27 IsoLoc Prostate Immobilization Treatment Balloon Device Kit |
| 20851546007145 - Photon MicroPSD | 2018-07-27 Photon-calibrated microPSD sensor cable |
| 00851546007158 - QC MicroPSD | 2018-07-27 QC-calibrated microPSD sensor cable |
| 20851546007213 - IsoLoc | 2018-07-27 IsoLoc Short Profile Prostate Immobilization Treatment Balloon Device Kit |