Visitec®

Basic Information

• Brand Name: Visitec®
• Primary DI: 30886158101278
• Version / Model: 585019
• Catalog Number: 585019
• Company Name: Beaver-Visitec International, Inc.
• Labeler DUNS: 001406024
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2021-11-01
• Public Version: 2
• Public Version Date: 2021-11-12
• Public Version Status: Update
• Public Device Record Key: 67e39036-828e-4dae-a70c-02b24ed0d02a

Device Description

Retrobulbar (Curved) [Atkinson / Straus] .50 x 34mm (25G x 1 3/8in 10

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: 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
GAA	Needle, Aspiration And Injection, Disposable	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47610	Ophthalmic needle, single-use	A slender, straight hollow instrument, usually with a sharp bevelled end, designed to be used with a syringe for the transient delivery of fluid materials (e.g., anaesthetic agents, therapeutic drugs) to various structures in and around the eye, including the eye muscles, or to an intraocular implant; it may also be intended for aspiration (e.g., aqueous humour). It is made of metal and/or plastic materials and may include a needle positioning and perforation depth guide. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00886158101277	GS1
Primary	30886158101278	GS1

Customer Contacts

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