GYRUS ACMI

Basic Information

• Brand Name: GYRUS ACMI
• Primary DI: 00821925010406
• Version / Model: 5720006
• Company Name: Gyrus Acmi, Inc.
• Labeler DUNS: 007198742
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-10-03
• Public Version: 3
• Public Version Date: 2023-10-16
• Public Version Status: Update
• Public Device Record Key: bc57bd87-e7c8-49f9-a54e-a8efc11f2ad2

Device Description

Surlok Stone Grasping Forceps Nonretracting 3.0 FR (1.0 mm) X 120 cm basket Width: 16 mm # of Wires: 3

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
FGO	DISLODGER, STONE, FLEXIBLE	Gastroenterology, Urology	876.4680	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46685	Flexible endoscopic stone-retrieval forceps, single-use	A flexible manual device intended to be inserted through the working channel of a compatible flexible endoscope to grasp and remove stones (e.g., calculi from the urinary tract) or foreign bodies during an endoscopic procedure. It is typically a flexible metal coil or plastic tube whose distal end is equipped with a pair of thin grasping claws in which the stone is seized and held for extraction. The claws are operated by a control handle at the proximal end of the instrument. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00821925010406	GS1