DISPOSABLE 20GA VITRECTOMY CUTTER & IRRI

Basic Information

• Brand Name: DISPOSABLE 20GA VITRECTOMY CUTTER & IRRI
• Primary DI: 05050474534094
• Version / Model: NGP0020
• Catalog Number: NGP0020
• Company Name: JOHNSON & JOHNSON SURGICAL VISION, INC.
• Labeler DUNS: 103021940
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-02
• Public Version: 4
• Public Version Date: 2020-02-26
• Public Version Status: Update
• Public Device Record Key: d1bbd8f4-58d9-4c00-9acb-494fd96a571e

Device Description

VITREOUS CUTTER, 20G, HIGH SPEED(6 PACK)

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: No
• 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
MLZ	VITRECTOMY, INSTRUMENT CUTTER	Ophthalmic	886.4150	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34125	Vitrectomy system handpiece	A holder for a detachable, micro-cutting tip that converts the energy (e.g., ultrasonic, piezoelectric) produced by a system generator into a mechanical oscillating-cutting action to remove (nibble away) vitreous humour (the jelly-like substance that fills the centre of the eye) during ophthalmic surgery. This device will typically be activated by the surgeon using a foot control and provide or support the irrigation/suction systems needed to supply replacement fluid and remove debris. The handpiece is typically designed in the form of a pen or pencil, and connected to the generator via a cable. This is a reusable device intended to be sterilized prior to use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05050474534094	GS1
Package	15050474534091	GS1	Box	6	In Commercial Distribution

Customer Contacts

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