SIR-Spheres Syringe Shield

Basic Information

• Brand Name: SIR-Spheres Syringe Shield
• Primary DI: 00850014612085
• Version / Model: SIR-S001
• Company Name: SIRTEX MEDICAL PTY LTD
• Labeler DUNS: 755092467
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-07-09
• Public Version: 2
• Public Version Date: 2022-01-19
• Public Version Status: Update
• Public Device Record Key: 9c37f2e5-9f08-49f3-9a51-edaae0f38e33

Device Description

SIR-Spheres Syringe Shield

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IWR	Holder, Syringe, Lead	Radiology	892.6500	1

GMDN Terms

Code	Name	Definition	Implantable	Status
38379	Syringe radiation shield	A radiation protective device made to surround a syringe while radioactive material is drawn up into the syringe and during patient injection. It is intended to shield the user from unnecessary exposure to radiopharmaceuticals or other radioactive material used in diagnostic or therapeutic procedures. It is typically made of lead (Pb), lead with a leaded glass insert, or clear lead-equivalent plastic materials.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850014612085	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]