Gyrus ACMI

Basic Information

• Brand Name: Gyrus ACMI
• Primary DI: 00821925030848
• Version / Model: 70338032R
• 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: 2023-09-28
• Public Version Status: Update
• Public Device Record Key: e726378f-3389-4a38-9934-17e8be4ac7af
• Distribution End Date: 2017-08-17

Device Description

STAPES H'PC F/DIEGO (NO EEPROM) REFURBISHED

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: No
• 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
ERL	DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE	Ear, Nose, Throat	874.4250	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34848	Metal/carbide ENT bur, single-use	A small rotary shaft of hard metal (e.g., steel) or carbide, with fluting or cutting planes of various shapes at the working end, designed for incising or removing cartilage and/or bone from the ear, nose, or throat during an ear/nose/throat (ENT) procedure. It is usually power-driven by a rotary handpiece or other powered device. It is typically used in mastoid surgery, frontal sinus surgery, or surgery of the facial nerves. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00821925030848	GS1

Premarket Submissions

Submission Number	Supplement Number
K992994	000