Amplatzer™

Basic Information

• Brand Name: Amplatzer™
• Primary DI: 00811806010335
• Version / Model: Sizing Plate
• Catalog Number: 9-ASD-SZP
• Company Name: AGA MEDICAL CORPORATION
• Labeler DUNS: 966215829
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-12-11
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 7447b50a-0c0c-4d40-8759-bcd67944e4aa

Device Description

Sizing Plate

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: Yes
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FTY	TAPE, MEASURING, RULERS AND CALIPERS	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
60385	Atrial septal defect sizing plate	A sterile, plastic plate containing a series of holes of varying diameters intended to be used to measure the diameter of an inflated sizing balloon of a cardiac catheter to assist in determining the size of an atrial septal defect. It is typically used during transcatheter closure of the defect by positioning the balloon within the defect, recording the amount of fluid required to fill the balloon to the size of the defect, then refilling the balloon outside the body and passing it through the various holes of the plate to determine the diameter. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00811806010335	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry.