Harmon Face Values - PROOPTICS LLC

Duns Number:002977189

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More Product Details

Catalog Number

-

Brand Name

Harmon Face Values

Version/Model Number

225FV

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K875197,K875197

Product Code Details

Product Code

LRX

Product Code Name

Case, Contact Lens

Device Record Status

Public Device Record Key

23d987a2-c7d2-4e7a-985d-ee3173a907bd

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

December 09, 2016

Additional Identifiers

Package DI Number

30075063122502

Quantity per Package

144

Contains DI Package

00075063122501

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton

"PROOPTICS LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 6