Product code IWW
- Device name
- Shield, Vial
- Medical specialty
- Radiology
- Device class
- 1
- Regulation number
- 892.6500
- Review panel
- RA
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K934548 | ALL-VUE & GAMMA-VUE VIAL SHIELDS | Victoreen, Inc. | 1993-11-12 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10815112021365 | Vented Cap for Waste Bottle | Bracco Diagnostics Inc. | 2023-10-16 |
| 10815112021372 | Waste Bottle | Bracco Diagnostics Inc. | 2023-10-16 |
| 30815112021369 | Vented Cap for Waste Bottle | BRACCO DIAGNOSTICS INC | 2023-10-16 |
| 30815112021376 | Waste Bottle | BRACCO DIAGNOSTICS INC | 2023-10-16 |
| 30815112021383 | Elution Test Vial Shield | Bracco Diagnostics Inc. | 2023-06-23 |
| 10815112020047 | Vented Cap for Waste Bottle | Bracco Diagnostics Inc. | 2023-03-22 |
| 10815112020054 | Waste Bottle | Bracco Diagnostics Inc. | 2023-03-22 |
| 30815112020041 | Vented Cap for Waste Bottle | BRACCO DIAGNOSTICS INC | 2023-03-22 |
| 30815112020058 | Waste Bottle | BRACCO DIAGNOSTICS INC | 2023-03-22 |
| 30815112020072 | Elution Test Vial | Bracco Diagnostics Inc. | 2023-03-22 |
| 10815112020085 | Elution Test Vial Shield | Bracco Diagnostics Inc. | 2023-03-21 |
| 00879942070088 | Tungsten Vial Shield with Magnetic Cap | Mirion Technologies (capintec), Inc. | 2022-07-11 |
| 00879942070071 | Vial Shield, Lead with Magnetic Cap and Glass Window | Mirion Technologies (capintec), Inc. | 2022-07-11 |
| 00879942070064 | Vial Shield, Lead with Magnetic Cap | Mirion Technologies (capintec), Inc. | 2022-07-11 |
| 00879942070040 | Dose Drawing Vial Shield, PET 50 ml | Mirion Technologies (capintec), Inc. | 2022-07-11 |
| 00879942070033 | Dose Drawing Vial Shield, PET 30 ml | Mirion Technologies (capintec), Inc. | 2022-07-11 |
| 00879942070026 | Vial Shield, Lead | Mirion Technologies (capintec), Inc. | 2022-07-11 |
| 00879942070019 | PET Vial Pig | Mirion Technologies (capintec), Inc. | 2022-07-11 |
| 00879942070002 | High Density Lead Glass Vial Shield | Mirion Technologies (capintec), Inc. | 2022-07-11 |
| 00879942070095 | Tungsten Vial Shield | Mirion Technologies (capintec), Inc. | 2022-07-11 |
| 00850014612078 | SIR-Spheres V-Vial Holder | Sirtex Medical Inc. | 2021-07-14 |
| 00850014612016 | SIROS D-Vial Prep Set | Sirtex Medical Inc. | 2021-01-05 |
| 00718175008478 | VIAL SHIELD | BIODEX MEDICAL SYSTEMS, INC. | 2020-04-13 |
| 00718175008614 | VIAL SHIELD | BIODEX MEDICAL SYSTEMS, INC. | 2020-04-13 |
| 00718175008850 | VIAL SHIELD | BIODEX MEDICAL SYSTEMS, INC. | 2020-04-13 |
| 00718175009086 | VIAL SHIELD | BIODEX MEDICAL SYSTEMS, INC. | 2020-04-13 |
| 00859942006317 | Capintec 511 T-Vial Shield | Mirion Technologies (capintec), Inc. | 2019-07-01 |
| 00718175000809 | VIAL SHIELD | BIODEX MEDICAL SYSTEMS, INC. | 2019-04-12 |
| 00718175000755 | HIGH DENSITY LEAD GLASS VIAL SHIELD | BIODEX MEDICAL SYSTEMS, INC. | 2019-04-10 |
| 00859942006263 | Capintec T-Vial Shield | Mirion Technologies (capintec), Inc. | 2018-11-28 |