RETRECTOR®

GUDID 00856222004667

1 Each Disposable 23 Ga vitrectomy probe with retractable tip for use with the INTRECTOR® Kit during vitreo-retinal surgery

INSIGHT INSTRUMENTS, INC.

Vitrectomy system handpiece tip

• Primary Device ID: 00856222004667
• NIH Device Record Key: 4422a790-b4ea-4d7a-ae08-0605b5c4f3a8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RETRECTOR®
• Version Model Number: 71005.100
• Company DUNS: 828348391
• Company Name: INSIGHT INSTRUMENTS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (772) 219-9393
• Email: CustomerService@InsightInstruments.com

Device Dimensions

• Needle Gauge: 23 Gauge

Device Identifiers

Device Issuing Agency	Device ID
GS1	00856222004667 [Primary]

FDA Product Code

• HKP: Instrument, Vitreous Aspiration And Cutting, Battery-Powered

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-23

On-Brand Devices [RETRECTOR®]

• 10856222004671: 1 RETRECTOR® Probe Kit containing 1 Each Syringe 10ml & 1 Each Disposable 23 Ga Vitrectomy Prob
• 00856222004667: 1 Each Disposable 23 Ga vitrectomy probe with retractable tip for use with the INTRECTOR® Kit d