Vacuum Tubing - Disposable Tubing for use with the ML7 - MED LOGICS INC

Duns Number:075390489

Device Description: Disposable Tubing for use with the ML7 Microkeratome

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More Product Details

Catalog Number

ML8060VS

Brand Name

Vacuum Tubing

Version/Model Number

ML8060VS

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

KYG

Product Code Name

Device, Irrigation, Ocular Surgery

Device Record Status

Public Device Record Key

03b98299-8716-4cf6-bb25-989229dc654b

Public Version Date

July 04, 2022

Public Version Number

2

DI Record Publish Date

August 27, 2020

Additional Identifiers

Package DI Number

10850724001206

Quantity per Package

10

Contains DI Package

00850724001209

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Bag

"MED LOGICS INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 32