Product code IWR
- Device name
- Holder, Syringe, Lead
- 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 |
|---|---|---|---|
| K934549 | ALL-VUE ULTRA-LITE THIN WALL SYRINGE SHIELD | Victoreen, Inc. | 1994-02-19 |
| K872656 | LEAD GLASS SHIELDS | Viox Corp. | 1987-07-16 |
| K863936 | DUFFY BOLUS INJECTOR | Viox Corp. | 1987-01-06 |
| K811688 | TUNGSTEN SYRINGE SHIELD | Medi-Physics Inc. Dba Nycomed Amersham Imaging | 1981-07-02 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 03701430100113 | Mediclic HE | LEMER PAX | 2024-02-09 |
| 03701430100298 | Mediclic LE | LEMER PAX | 2024-02-09 |
| 03701430100465 | Easyview LE | LEMER PAX | 2024-02-09 |
| 03701430100496 | Easyview LE | LEMER PAX | 2024-02-09 |
| 03701430100526 | Easyview LE | LEMER PAX | 2024-02-09 |
| 03701430100601 | EASYSQUEEZE | LEMER PAX | 2023-12-25 |
| 03701430100618 | EASYSQUEEZE | LEMER PAX | 2023-12-25 |
| 00859942006607 | Pro-Tec IV 3 cc | Mirion Technologies (capintec), Inc. | 2022-07-11 |
| 00859942006706 | Dose Drawing Syringe Shield, 3 cc, with Replaceable Glass | Mirion Technologies (capintec), Inc. | 2022-07-11 |
| 00859942006614 | Pro-Tec IV 5 cc | Mirion Technologies (capintec), Inc. | 2022-07-11 |
| 00859942006621 | Pro-Tec IV 10 cc | Mirion Technologies (capintec), Inc. | 2022-07-11 |
| 00859942006638 | Beta Syringe Shield, 1 cc | Mirion Technologies (capintec), Inc. | 2022-07-11 |
| 00859942006645 | Beta Syringe Shield, 10 cc | Mirion Technologies (capintec), Inc. | 2022-07-11 |
| 00859942006652 | Beta Syringe Shield, 20 cc | Mirion Technologies (capintec), Inc. | 2022-07-11 |
| 00859942006669 | "Syringe Carrier, Large 0.125"" lead" | Mirion Technologies (capintec), Inc. | 2022-07-11 |
| 00859942006676 | Dose Drawing Syringe Shield, 3 cc | Mirion Technologies (capintec), Inc. | 2022-07-11 |
| 00859942006683 | Dose Drawing Syringe Shield, 5/6 cc | Mirion Technologies (capintec), Inc. | 2022-07-11 |
| 00859942006690 | Dose Drawing Syringe Shield, 10/12 cc | Mirion Technologies (capintec), Inc. | 2022-07-11 |
| 00859942006591 | Pro-Tec IV 1 cc | Mirion Technologies (capintec), Inc. | 2022-07-11 |
| 00859942006584 | Pro-Tec III 2.5 cc | Mirion Technologies (capintec), Inc. | 2022-07-11 |
| 00859942006577 | Pro-Tec III 10 cc | Mirion Technologies (capintec), Inc. | 2022-07-11 |
| 00859942006560 | Pro-Tec III 5 cc | Mirion Technologies (capintec), Inc. | 2022-07-11 |
| 00859942006553 | Pro-Tec III 3 cc | Mirion Technologies (capintec), Inc. | 2022-07-11 |
| 00859942006546 | Pro-Tec III 1 cc | Mirion Technologies (capintec), Inc. | 2022-07-11 |
| 00859942006539 | Pro-Tec III 1 cc, BD Luer Lok | Mirion Technologies (capintec), Inc. | 2022-07-11 |
| 00859942006522 | Pro-Tec II 5 cc | Mirion Technologies (capintec), Inc. | 2022-07-11 |
| 00859942006515 | Pro-Tec II 5 cc with lead glass window | Mirion Technologies (capintec), Inc. | 2022-07-11 |
| 00859942006508 | Pro-Tec II 3 cc without glass window | Mirion Technologies (capintec), Inc. | 2022-07-11 |
| 00859942006492 | Pro-Tec II 3 cc with lead glass window | Mirion Technologies (capintec), Inc. | 2022-07-11 |
| 00850014612085 | SIR-Spheres Syringe Shield | Sirtex Medical Inc. | 2021-07-09 |