Ambler Surgical

Basic Information

• Brand Name: Ambler Surgical
• Primary DI: 00190660144883
• Version / Model: Bailey aortic rongeur
• Catalog Number: 75-146
• Company Name: AMBLER SURGICAL CORP.
• Labeler DUNS: 015272206
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-01-07
• Public Version: 1
• Public Version Date: 2021-01-15
• Public Version Status: New
• Public Device Record Key: c5073243-783d-40d1-914a-5bf15f6062f5

Device Description

Bailey aortic rongeur, working length 125mm, angled down 90 degrees jaws, 3.0mm bite, ring handle

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: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DWS	INSTRUMENTS, SURGICAL, CARDIOVASCULAR	Cardiovascular	870.4500	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35285	Aorta punch, reusable	A manual surgical instrument designed to cut a circular 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 corresponds to the size of the hole. Behind the tip is a thinner section which entraps (holds) the tissue as the sharp circular blade is pressed down the plunger by the surgeon into and through the tissue. It is typically made of high-grade stainless steel and is available in various punch sizes. It can equally be used to punch holes in other vessels if needed. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00190660144883	GS1

Customer Contacts

• Phone: [phone] ext. 0
• Email: [email protected]