1-Day Flat Pack Trial9 BC840 - MENICON CO.,LTD.

Duns Number:690680533

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More Product Details

Catalog Number

-

Brand Name

1-Day Flat Pack Trial9 BC840

Version/Model Number

+2.00

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)

-

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

LPL

Product Code Name

Lenses, Soft Contact, Daily Wear

Device Record Status

Public Device Record Key

df4aa903-0d55-4a2c-8ef6-c67e1a2c7688

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 31, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MENICON CO.,LTD." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 3853
3 A medical device with high risk that requires premarket approval 2