AVALIGN

Basic Information

• Brand Name: AVALIGN
• Primary DI: 00850011214077
• Version / Model: PMI-RD-D
• Catalog Number: PMI-RD-D
• Company Name: PROGRESSIVE MEDICAL INSTRUMENTATION INC
• Labeler DUNS: 131054074
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-09-06
• Public Version: 2
• Public Version Date: 2021-07-22
• Public Version Status: Update
• Public Device Record Key: 7649be5b-34d3-450e-8c38-ab6aa2c3de18

Device Description

APPROXIMATOR CLAMPS W/O FRAME

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: Yes
• 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
DXC	Clamp, Vascular	Cardiovascular	870.4450	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62471	Coronary artery clamp	A hand-held, manual surgical instrument designed to directly compress a coronary artery during coronary artery graft surgery to create a temporary atraumatic haemostasis (arrest or prevention of bleeding). It may be referred to as a clip or a clamp, is made of plastic, and has a self-retaining design; it is not in the form of a bulldog clamp nor scissors-like forceps. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850011214077	GS1

Customer Contacts

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