Insight Instruments, Inc. Vitreous Biopsy Probe 27 Ga

GUDID 00852475007004

1 Each Sterile Disposable 27 Ga Vitreous Biopsy Probe for use with the INTRECTOR® Kit

INSIGHT INSTRUMENTS, INC.

Vitrectomy system handpiece tip

• Primary Device ID: 00852475007004
• NIH Device Record Key: 48eb96b2-1e06-4208-9da8-7721ac4e69dd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Insight Instruments, Inc. Vitreous Biopsy Probe 27 Ga
• Version Model Number: 71007.100
• 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: 27 Gauge

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852475007004 [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 [Insight Instruments, Inc. Vitreous Biopsy Probe 27 Ga]

• 00852475007011: Dispenser Box of 5 Each Sterile Disposable 27 Ga Vitreous Biopsy Probes for use with the INTRECT
• 00852475007004: 1 Each Sterile Disposable 27 Ga Vitreous Biopsy Probe for use with the INTRECTOR® Kit