INTRECTOR®

Basic Information

• Brand Name: INTRECTOR®
• Primary DI: 00856222004643
• Version / Model: 71004.100
• Company Name: INSIGHT INSTRUMENTS, INC.
• Labeler DUNS: 828348391
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 09621cee-e689-4953-ba16-9a8a8ee976d3

Device Description

1 Disposable 23 Ga Vitrectomy Probe for use with the INTRECTOR® KIT

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: 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
HKP	Instrument, Vitreous Aspiration And Cutting, Battery-Powered	Ophthalmic	886.4150	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47424	Vitrectomy system handpiece tip	A sterile, micro-cutting device that is attached to a vitrectomy system handpiece for insertion into the eye, in order to remove (nibble away) the vitreous humour (the jelly-like substance that fills the centre of the eye) during ophthalmic surgery. The handpiece converts an energy (e.g., ultrasonic, piezoelectric) produced by a system generator into a mechanical oscillating-cutting action applied by this knife-like device. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00856222004643	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Needle Gauge	23	Gauge