4420CE

GUDID 00812480010215

20 Gauge Vitreous Cutter, AP, Extended Use, Non-Sterile

MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.

Vitrectomy system handpiece Vitrectomy system handpiece

• Primary Device ID: 00812480010215
• NIH Device Record Key: c2951f1c-0d48-431d-a8e2-bd7ec40cc4ed
• Commercial Distribution Discontinuation: 2018-01-04
• Commercial Distribution Status: Not in Commercial Distribution
• Version Model Number: 4420CE
• Catalog Number: 4420CE
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• 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: 20 Gauge
• Needle Gauge: 20 Gauge

Operating and Storage Conditions

• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812480010215 [Primary]
GS1	10812480010212 [Package]; Package: Carton [3 Units]; Discontinued: 2018-01-04; Not in Commercial Distribution

FDA Product Code

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

Sterilization

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

[00812480010215]

Moist Heat or Steam Sterilization

[00812480010215]

Moist Heat or Steam Sterilization

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

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