Gyrus ACMI

Basic Information

• Brand Name: Gyrus ACMI
• Primary DI: 00821925042391
• Version / Model: 890912
• Company Name: Gyrus ACMI, LLC
• Labeler DUNS: 007198742
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-07-25
• Public Version: 2
• Public Version Date: 2024-09-02
• Public Version Status: Update
• Public Device Record Key: 86801168-f3fa-4dc7-848e-7f20c71ddac4

Device Description

EPISTAXIS BALOON CATHETER KIT. CONTAINS: ONE CATHETER, ONE 10 CC SYRINGE AND TWO 4 x 4". GAUZE PADS

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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
EMX	Balloon, Epistaxis	Ear, Nose, Throat	874.4100	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64402	Intranasal splint, non-bioabsorbable, animal-derived	A non-bioabsorbable device intended to be temporarily placed via a nostril into the nasal cavity after surgery or trauma to help minimize bleeding by tamponade effect, prevent adhesions between the mucosal surfaces, and/or provide support to the surrounding tissues during the healing period. It is made from animal-derived materials (e.g., chitosan) and is removed at the discretion of the physician. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00821925022379	GS1		1	In Commercial Distribution
Primary	00821925042391	GS1