SIR-Spheres V-Vial Holder
Catalogue number SIR-H001, listed by Sirtex Medical Inc., United States, under Shield, Vial. 1 manufacturer in China is registered for this product code.
1manufacturer
1catalogue number
Who Else Makes It
Registered in Zhejiang.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Ningbo Tianbo First AID Product Co., Ltd. | Ningbo | Zhejiang | Repacker / relabeller | 66 |
Record
| Listed by | Sirtex Medical Inc., United States |
|---|---|
| FDA product code | IWW |
| Device type | Shield, Vial |
| Device class | Class 1 |
| Regulation | 21 CFR 892.6500 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-07-14 |
| Record revised | 2026-06-08 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SIR-H001 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Vial Shield | Biodex Medical Systems, Inc. | 5 |
| Vented Cap for Waste Bottle | Bracco Diagnostics, Inc. | 2 |
| Elution Test Vial Shield | Bracco Diagnostics, Inc. | 2 |
| Waste Bottle | Bracco Diagnostics, Inc. | 2 |
| Tungsten Vial Shield | Mirion Technologies (Capintec), Inc | 1 |
| Vial Shield, Lead | Mirion Technologies (Capintec), Inc | 1 |
| PET Vial PIG | Biodex Medical Systems, Inc. | 1 |
| High Density Lead Glass Vial Shield | Mirion Technologies (Capintec), Inc | 1 |
| Capintec T-Vial Shield | Mirion Technologies (Capintec), Inc | 1 |
| Dose Drawing Vial Shield, PET 30 ml | Mirion Technologies (Capintec), Inc | 1 |
| PET Vial Pig | Mirion Technologies (Capintec), Inc | 1 |
| Vial Shield, Lead with Magnetic Cap | Mirion Technologies (Capintec), Inc | 1 |
Showing 12 of 21. All products under Shield, Vial
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.