Nutrifill - Ultra-Pure Nutrient Rich Specialty Lens Fill - CONTAMAC SOLUTIONS, INC.

Duns Number:117592637

Device Description: Ultra-Pure Nutrient Rich Specialty Lens Fill Solution

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More Product Details

Catalog Number

-

Brand Name

Nutrifill

Version/Model Number

Nutrifill

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K181566,K181566

Product Code Details

Product Code

MRC

Product Code Name

Products, Contact Lens Care, Rigid Gas Permeable

Device Record Status

Public Device Record Key

c2cb453e-e21c-49be-917c-5400b2bd7acf

Public Version Date

August 28, 2020

Public Version Number

1

DI Record Publish Date

August 20, 2020

Additional Identifiers

Package DI Number

10850012123009

Quantity per Package

12

Contains DI Package

00850012123002

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box

"CONTAMAC SOLUTIONS, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 1