Aurotrocar

Basic Information

• Brand Name: Aurotrocar
• Primary DI: 10803878053058
• Version / Model: ATS-23G
• Company Name: AUROLAB
• Labeler DUNS: 677319965
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-06-27
• Public Version: 1
• Public Version Date: 2023-07-05
• Public Version Status: New
• Public Device Record Key: 8ee2f594-373e-4f17-afb5-e1e4e424f90b
• Distribution End Date: 2023-06-29

Device Description

Trocar set is a sterile single use medical device consisting of Stainless steel Trocar needle glued to a plastic handle in which the Cannula appended with valved silicone closure valve slides over it. This assembly is secured by a plastic cap. It is supplied along with one silicone tube inserted with an infusion adaptor and a Luer lock adaptor on either ends which is called as infusion line. A Trocar set encompasses 3 Trocar handle with cap and one infusion line.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: Yes
• 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
NGY	Cannula, Trocar, Ophthalmic	Ophthalmic	886.4350	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46840	Ophthalmic cannulation set, single-use	A collection of non-powered devices intended to be used to create a channel into the eye for posterior segment ophthalmic surgery [e.g., infusion and/or aspiration of an ophthalmic replacement medium (e.g., silicone oil)]. It consists of metal cannulae, often with tubing, and includes additional ophthalmic instruments/devices intended to support the cannulation procedure (e.g., a trocar, plug, syringe, filter); it may be used in conjunction with a dedicated pump (not included) for pressure-controlled fluid delivery. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10803878053058	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]