Ultimate Vit Enhancer™ 6400

GUDID 00812480010994

Ultimate Vit Enhancer™, 8000cpm capable

MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.

Vitrectomy system

• Primary Device ID: 00812480010994
• NIH Device Record Key: 6d8b7987-cb7f-4e27-a27d-9adccf2a7432
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ultimate Vit Enhancer™
• Version Model Number: 6400
• Catalog Number: 6400
• 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: false
• Serial Number: true
• 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

• Height: 11 Inch
• Height: 11 Inch
• Height: 11 Inch
• Height: 11 Inch
• Height: 11 Inch
• Height: 11 Inch

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep Dry

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812480010994 [Primary]

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: false

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

Devices Manufactured by MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.

• 00812480011007 - Bi-Blade®: 2023-08-22 27 Gauge BB Vitreous Cutter, 20 psi, Luer Anterior PVC Tubing Set, Sterile, Single Use
• 10812480011035 - Bi-Blade®: 2023-08-22 27 Gauge BB Vitreous Cutter, 25 psi, Luer Anterior PVC Tubing Set, Sterile, Single Use
• 10812480011219 - NA: 2021-05-05 Cannula Insertion System, 27 Gauge, Sterile, Single Step, Generic, w/ Tubing Set
• 10812480011233 - NA: 2021-05-05 Cannula Insertion System, 25 Gauge, Sterile, Single Step, Generic, w/ Tubing Set
• 10812480011257 - NA: 2021-05-05 Cannula Insertion System, 23 Gauge, Sterile, Single Step, Generic, w/ Tubing Set
• 10812480011028 - Bi-Blade®: 2018-12-17 25 Gauge BB Vitreous Cutter, R1+, w/ 79” Anterior Tubing Set, Sterile, Single Use, 1ea
• 10812480011042 - Bi-Blade®: 2018-12-17 27 Gauge BB Vitreous Cutter, R4+, w/ 72” Anterior Tubing Set, Sterile, Single Use
• 10812480011196 - Bi-Blade®: 2018-12-17 27 Gauge BB Vitreous Cutter, R3A, w/ 72” Anterior Tubing Set, Sterile, Single Use