| Primary Device ID | 00850020470075 |
| NIH Device Record Key | 8edea838-98e6-4490-b9d4-f8f4d418216a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | RadQual |
| Version Model Number | BM03-22A |
| Company DUNS | 008841076 |
| Company Name | RADQUAL, 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 | false |
| Lot Batch | false |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850020470075 [Primary] |
| IXD | Source, Calibration, Sealed, Nuclear |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-08-11 |
| Device Publish Date | 2020-08-03 |
| 00850020470006 | Rect 18" x24" Phantom Co 57 |
| 00850020470525 | Co 57 Neurologica Line Source |
| 00850020470518 | Co 57 Rigid Ruler |
| 00850020470501 | Co 57 Flexible Ruler |
| 00850020470495 | Co 57 Flexible Line Source |
| 00850020470488 | Penpoint Marker |
| 00850020470471 | Ge-68 Rod Source |
| 00850020470464 | Co 57 Rod Source |
| 00850020470457 | Cs 137 Rod Source |
| 00850020470440 | Ba-133 Rod Source |
| 00850020470433 | Na-22 Rod Source |
| 00850020470426 | Eu-152 Rod Source |
| 00850020470419 | Ge 68 20cc Multidose Vial |
| 00850020470402 | Co 60 20cc Multidose Vial |
| 00850020470396 | Co-57 20cc Multidose Vial |
| 00850020470389 | Cs-137 20cc Multidose Vial |
| 00850020470372 | Ba-133 20cc Multidose Vial |
| 00850020470365 | Ge 68 10cc Multidose Vial |
| 00850020470358 | Co 60 10cc Multidose Vial |
| 00850020470341 | Co-57 10cc Multidose Vial |
| 00850020470334 | Cs-137 10cc Multidose Vial |
| 00850020470327 | Ba-133 10cc Multidose Vial |
| 00850020470310 | Ge 68 5cc Multidose Vial |
| 00850020470303 | Co 60 5cc Multidose Vial |
| 00850020470297 | Co-57 5cc Multidose Vial |
| 00850020470280 | Cs-137 5cc Multidose Vial |
| 00850020470273 | Ba-133 5cc Multidose Vial |
| 00850020470266 | Ge 68 syringe |
| 00850020470259 | Co 60 Syringe |
| 00850020470242 | Co-57 Syringe |
| 00850020470235 | Cs-137 Syringe |
| 00850020470228 | Ba-133 Syringe |
| 00850020470211 | Co 60 "E" Vial |
| 00850020470204 | Co 57 "E" Vial |
| 00850020470198 | Cs-137 "E" Vial |
| 00850020470181 | BA-133 "E" Vial |
| 00850020470174 | 1" Dia. Spot Source Ba-133 |
| 00850020470167 | 1" Dia. Spot Source Ge-68 |
| 00850020470150 | 1" Dia. Spot Source Ge-68 NIST calibrated |
| 00850020470143 | 1" Dia. Al Spot Source Ge-68 |
| 00850020470136 | 1" Dia. Left Right Markers Co 57 |
| 00850020470129 | 1" Dia. Spot Source Co 57 |
| 00850020470112 | 1" Dia. Al Spot Source Co-57 |
| 00850020470105 | 1" Dia. Spot Source Sodium w Teflon CT markers |
| 00850020470099 | 1" Dia. Al Spot Source Sodium 22 |
| 00850020470082 | 1" Dia. Spot Source Cesium 137 |
| 00850020470075 | 1" Dia. Al Spot Source Sodium 22 |
| 00850020470068 | 1" Dia. Al Spot Source Cesium 137 |
| 00850020470051 | Square 12" x 12" Phantom Co 57 |
| 00850020470044 | Rect 10" x 16" Phantom Co 57 |