Ultimate Vit Enhancer™ 6400

GUDID 00812480010994

Ultimate Vit Enhancer™, 8000cpm capable

MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.

Vitrectomy system
Primary Device ID00812480010994
NIH Device Record Key6d8b7987-cb7f-4e27-a27d-9adccf2a7432
Commercial Distribution StatusIn Commercial Distribution
Brand NameUltimate Vit Enhancer™
Version Model Number6400
Catalog Number6400
Company DUNS790265227
Company NameMEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1(800)929-5227
Emailqa@midlabs.com
Phone1(800)929-5227
Emailqa@midlabs.com

Device Dimensions

Height11 Inch
Height11 Inch
Height11 Inch
Height11 Inch
Height11 Inch
Height11 Inch

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry

Device Identifiers

Device Issuing AgencyDevice ID
GS100812480010994 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HQEInstrument, Vitreous Aspiration And Cutting, Ac-Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-23

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