2960CE

GUDID 10812480010366

27 Gauge Vitreous Cutter, R4, w/ 79” CPC Tubing Set, Sterile, Single Use

MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.

Vitrectomy system micro-cutting unit

• Primary Device ID: 10812480010366
• NIH Device Record Key: 97440fb3-163e-4c08-b248-b10fe5cfbf10
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 2960CE
• Catalog Number: 2960CE
• Company DUNS: 790265227
• Company Name: MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, 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: false
• 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: 1(800)929-5227
• Email: qa@midlabs.com
• Phone: 1(800)929-5227
• Email: qa@midlabs.com

Device Dimensions

• Needle Gauge: 27 Gauge
• Needle Gauge: 27 Gauge

Operating and Storage Conditions

• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 98 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812480010369 [Primary]
GS1	10812480010366 [Package]; Contains: 00812480010369; Package: Carton [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102222

FDA Product Code

• HQE: Instrument, Vitreous Aspiration And Cutting, Ac-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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-23

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• 10812480011028 - Bi-Blade®: 2018-12-17 25 Gauge BB Vitreous Cutter, R1+, w/ 79” Anterior Tubing Set, Sterile, Single Use, 1ea
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• 10812480011196 - Bi-Blade®: 2018-12-17 27 Gauge BB Vitreous Cutter, R3A, w/ 72” Anterior Tubing Set, Sterile, Single Use