Galactography Infusion Unit Galactography is a very important technique to guide successful surgery and minimize the amount of tissue removed in patients with significant nipple discharge. Galactography can reduce the amount of unnecessary surgery when no lesion is found and provide a preoperative diagnosis so that the proper surgical approach may enable us to outline an entire duct segment containing ductal carcinoma in situ serving as a road-map for complete surgical excision of the cancer and eliminating recurrence. Ranfac's Galactography Infusion Units are designed to provide ease of insertion with minimal patient discomfort and are available in 30 or 31 Gauge. Localization System Ranfac Localization System provides the radiologist with a complete sterile breast marking system, including a 20g Thin Wall needle and a flexible .010 marking wire. Catalog # Part # Description GIU-30 68008-05M Galactography Infusion Unit (30 Gauge) GIU-31 68008-06M Galactography Infusion Unit (31 Gauge) 30G-END 68008-03M Galactography Infusion Endport (30 Gauge) 31G-END 68008-07M Galactography Infusion Endport (31 Gauge) SBS-5 60004-01M Sadowski Breast Marking System (5cm) SBS-7.5 60004-03M Sadowski Breast Marking System (7.5cm) SBS-10 60004-02M Sadowski Breast Marking System (10cm) SC-3CM 60001-01M Stiffening Cannula (3cm) SC-4CM 60001-02M Stiffening Cannula (4cm) SC-5CM 60001-03M Stiffening Cannula (5cm) SC-6CM 60001-04M Stiffening Cannula (6cm) SC-7CM 60001-05M Stiffening Cannula (7cm) SC-8CM 60001-06M Stiffening Cannula (8cm) SC-9CM 60001-07M Stiffening Cannula (9cm) PRIVACY POLICY EVENTS & TRADESHOWS CAREERS QUALITY ASSURANCE E-IFU Ranfac Corp. 30 Doherty Ave. Avon, MA 02322 US: 1-800-272-6322 Int'l: 1-508-588-4400 info@ranfac.com

Quality Assurance Certifications: ISO 13485:2016 - Certificate of Registration ISO 13485:2016 - Certificate of Registration EC Certificate - Production Quality Assurance BSI VerifEye™ Directory Listing Quality Policy Ranfac Corp. is devoted to maintaining the continuing effectiveness of the Quality Management System. Ranfac Corp. employees are committed to deliver products that consistently meet or exceed the requirements and reasonable expectations of our customers. Ranfac Corp. is an ISO 13485:2016 certified medical device manufacturer. We are also certified to Directive 93/42 EEC and maintain compliance with the FDA, CGMP/QSR. Our system is designed to ensure that records are kept for trending purposes. This trending is reviewed with executive management regularly to ensure the system is staying in compliance and resulting in conforming product being shipped to all of our customers. Our Quality System is designed to identify and mitigate risk wherever possible. Some of the tools we utilize are: AQL sampling and Statistical Process Control to ensure product compliance. A calibration system that ensures all of our gauges are within calibration and are NIST traceable. FMEAs, Control Plans, Designs of Experiments, IQ/OQ/PQ protocols PRIVACY POLICY EVENTS & TRADESHOWS CAREERS QUALITY ASSURANCE E-IFU Ranfac Corp. 30 Doherty Ave. Avon, MA 02322 US: 1-800-272-6322 Int'l: 1-508-588-4400 info@ranfac.com