Avalign

Basic Information

• Brand Name: Avalign
• Primary DI: 00190776376758
• Version / Model: VM56-6286
• Company Name: Avalign Technologies, Inc.
• Labeler DUNS: 792528510
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-06-23
• Public Version: 2
• Public Version Date: 2023-07-06
• Public Version Status: Update
• Public Device Record Key: 4d8c8641-af17-43c6-a106-48b117179729

Device Description

Umbilical Scissor

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
HDJ	SCISSORS, UMBILICAL	Obstetrics/Gynecology	884.4520	1

GMDN Terms

Code	Name	Definition	Implantable	Status
32602	Umbilical cord scissors, reusable	A hand-held manual surgical instrument designed specifically to cut the umbilical cord after birth. It comprises two pivoted blades that are usually provided with a finger and thumb ring-handle and which cut with a shearing action (i.e., the blades cut as the sharpened edges pass one another as they are closed). It is metallic and is available in various designs and sizes; the blades can have a variety of sizes and designs, e.g., curved, acutely angled at the tip, or have flat opposing moon shapes, and may be serrated. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00190776376758	GS1

Customer Contacts

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