Holder, Syringe, Lead
A lead syringe holder is a radiation-shielding container or handle used to hold and transport syringes containing radioactive materials, protecting healthcare workers from radiation exposure during handling and administration of radiopharmaceuticals. It is classified as FDA Class 1, the lowest risk category, subject only to general controls. The product code is IWR, regulated under 21 CFR 892.6500, within the Radiology medical specialty.
Research product code IWR in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- IWR
- Device Class
- FDA class 1
- Regulation Number
- 892.6500
- Medical Specialty
- Radiology
- Review Panel
- RA
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K934549 | ALL-VUE ULTRA-LITE THIN WALL SYRINGE SHIELD | Feb 19, 1994 | Substantially Equivalent | Victoreen, Inc. |
| K872656 | LEAD GLASS SHIELDS | Jul 16, 1987 | Substantially Equivalent | Viox Corp. |
| K863936 | DUFFY BOLUS INJECTOR | Jan 06, 1987 | Substantially Equivalent | Viox Corp. |
| K811688 | TUNGSTEN SYRINGE SHIELD | Jul 02, 1981 | Substantially Equivalent | Medi-Physics Inc. Dba Nycomed Amersham Imaging |
FEI Numbers
This FDA classification entry is associated with 17 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 17 registration numbers. Click on an entry to view related FDA registrations.