Avalign

Basic Information

• Brand Name: Avalign
• Primary DI: 00190776049430
• Version / Model: VM105-2275
• Company Name: Avalign Technologies, Inc.
• Labeler DUNS: 792528510
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-09-28
• Public Version: 1
• Public Version Date: 2023-10-06
• Public Version Status: New
• Public Device Record Key: 87498fd3-4a21-4470-b704-999b6f48a649

Device Description

Laforce Adenotome, blade only,

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
KBH	ADENOTOME	Ear, Nose, Throat	874.4420	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35836	Adenotome blade, reusable	A surgical cutting edge that is designed to be mounted into the handle of an adenotome to excise the adenoids (hypertrophic lymphoid tissue in the nasopharynx) during an adenoidectomy. The device is typically a flat piece of metal (e.g., stainless steel) with one or both sharp edges at the working end; it is configured at its proximal end to attach to a particular type of adenotome. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00190776049430	GS1

Customer Contacts

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