GYRUS ACMI

Basic Information

• Brand Name: GYRUS ACMI
• Primary DI: 00821925033412
• Version / Model: 130785
• Company Name: Gyrus Acmi, Inc.
• Labeler DUNS: 007198742
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-09-10
• Public Version: 4
• Public Version Date: 2023-08-25
• Public Version Status: Update
• Public Device Record Key: ed9902bc-c6d3-43ba-bdf1-08108a5d3e08

Device Description

EAR SUCTION NEEDLE W/BYPASS 16 GAUGE DISPOSABLE

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: Yes
• 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
LRC	INSTRUMENT, ENT MANUAL SURGICAL	Ear, Nose, Throat	874.4420	1

GMDN Terms

Code	Name	Definition	Implantable	Status
60793	Surgical irrigation/aspiration handpiece, single-use	A hand-held device designed to be connected to a separate cannula/tip for both irrigation and aspiration of a surgical site by regulating and directing a stream of pressurized fluid (e.g., sterile water) to the site and facilitating suction of debris from the site. It is activated by the operator, typically through a push-type control(s); it may include connection tubing, however other associated devices (e.g., cannula/tip, clamps, filters, spikes) are not included (i.e., it is neither a tubing set nor an irrigation/aspiration cannula). It is typically intended for an ear/nose/throat (ENT) procedure or neurosurgical use; it is not an ophthalmic device. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00821925017818	GS1		6	In Commercial Distribution
Primary	00821925033412	GS1