SourceLink™ 5.0mm Extension SourceLink™

Basic Information

• Brand Name: SourceLink™ 5.0mm Extension SourceLink™
• Primary DI: 10801741078153
• Version / Model: 7030310
• Catalog Number: 7030310
• Company Name: Bard Brachytherapy, Inc.
• Labeler DUNS: 185524860
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2015-10-05
• Public Version: 3
• Public Version Date: 2022-10-31
• Public Version Status: Update
• Public Device Record Key: 1d7fb6a7-1296-44a5-ba03-7ebfabe7d1e3

Device Description

SourceLink™ 5.0mm Extension SourceLink™ - Model 7030310 Synthetic Absorbable Seeding Spacer Links, 10 ea

Device Characteristics

• Single Use: Yes
• 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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KXK	Source, brachytherapy, radionuclide	Radiology	892.5730	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46844	Brachytherapy source spacer	A sterile, bioabsorbable device designed to separate radioactive sources of the seed type that are permanently implanted in close proximity to a selected localized tumour, to increase the distribution of radioactivity to the tumour. It typically has a cylindrical form (of around 0.5 cm in length and less than 1 mm in diameter) and is made of bioabsorbable polymer materials. It may be used for the primary treatment of tumours (e.g., prostate cancer), or to treat unresectable tumours, recurring tumours, or residual disease. It is typically placed in the body by means of a remote-afterloading applicator using ultrasonic or fluoroscopic guidance.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10801741078153	GS1
Unit of Use	00801741078156	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K023210	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: High: 40 Degrees Celsius