GYRUS ACMI, INC

Basic Information

• Brand Name: GYRUS ACMI, INC
• Primary DI: 00821925022263
• Version / Model: 70921490
• Company Name: Gyrus Acmi, Inc.
• Labeler DUNS: 007198742
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-10-06
• Public Version: 5
• Public Version Date: 2023-11-21
• Public Version Status: Update
• Public Device Record Key: 44f6cf02-e761-4582-8436-176f78458036
• Distribution End Date: 2017-06-01

Device Description

FLUOROPLASTIC PISTON, .6MM DIAMETER,

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: No
• 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
ETB	PROSTHESIS, PARTIAL OSSICULAR REPLACEMENT	Ear, Nose, Throat	874.3450	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35690	Ossicular prosthesis, partial	A sterile device intended to be implanted for the functional reconstruction of segments of the ossicular chain (mallues, incus, and/or stapes bones) to facilitate the conduction of sound waves from the tympanic membrane to the inner ear. It is designed to treat conductive hearing loss from traumatic or surgical injury, otosclerosis, congenital fixation of the stapes, or chronic middle ear disease. The device is typically in the form of a tube made of metal [e.g., stainless steel, titanium (Ti)], polymers, or a combination of these materials.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00821925022263	GS1

Premarket Submissions

Submission Number	Supplement Number
K760435	000