Aortic Cutter 4.3MM

Basic Information

• Brand Name: Aortic Cutter 4.3MM
• Primary DI: 00607567700277
• Version / Model: AC-3043
• Catalog Number: AC-3043
• Company Name: MAQUET CARDIOVASCULAR LLC
• Labeler DUNS: 022348156
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 3
• Public Version Date: 2018-05-30
• Public Version Status: Update
• Public Device Record Key: 593d03b4-3675-4b9a-9033-198a5d84b5a6

Device Description

Aortic Cutter 4.3MM

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: Yes
• 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
FZT	Cutter, Surgical	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47914	Aorta punch, single-use	A sterile, manual surgical instrument designed to cut a circular or elliptical plug of tissue from the wall of the aorta to create an anastomosis site during vascular surgery. It consists of a pointed, cone-shaped, disk-like tip on the end of a plunger that is inserted through a small incision made; its diameter/size corresponds to the cut hole. Behind the tip is a thinner section which entraps (holds) the tissue as the sharp circular/elliptical blade is pressed down the plunger into and through the tissue. It is typically made of steel and plastic and is available in various punch sizes. It can equally be used to punch holes in other vessels when needed. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00607567700271	GS1	5 pack box	5	Not in Commercial Distribution	2018-05-29
Primary	00607567700277	GS1
Package	20607567700271	GS1	5 pack box	5	In Commercial Distribution

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Outer Diameter	4.3	Millimeter