Ultimate Vit Enhancer™

Basic Information

• Brand Name: Ultimate Vit Enhancer™
• Primary DI: 00812480010994
• Version / Model: 6400
• Catalog Number: 6400
• Company Name: MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.
• Labeler DUNS: 790265227
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 6d8b7987-cb7f-4e27-a27d-9adccf2a7432

Device Description

Ultimate Vit Enhancer™, 8000cpm capable

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HQE	Instrument, Vitreous Aspiration And Cutting, Ac-Powered	Ophthalmic	886.4150	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45074	Vitrectomy system	An assembly of ophthalmic devices intended to deliver energy (e.g., ultrasonic, piezoelectric, pneumatic) through a dedicated hand-held instrument, which converts the energy into an oscillating-cutting action to remove (nibble away) vitreous humour (the jelly-like substance that fills the centre of the eye) during ophthalmic surgery. This system will typically consist of a generator to provide the energy, an infusion and suction system to supply replacement fluid and remove debris, a cutting handpiece and cables, and a foot control. This assembly is typically used to treat diabetic vitreous haemorrhage, retinal detachment, epiretinal membrane, and macular hole.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00812480010994	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K102222	000

Device Sizes

Type	Value	Unit	Text
Depth	11.25	Inch
Width	6.75	Inch
Height	11	Inch

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -40 – 70 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 10 – 100 Percent (%) Relative Humidity
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 20 – 110 KiloPascal
• Type: Handling Environment Temperature
• Temperature Range: -40 – 70 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 10 – 100 Percent (%) Relative Humidity
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 20 – 110 KiloPascal
• Type: Special Storage Condition, Specify
• Special Conditions: Keep Dry