CLEAR CARE - CLEAR CARE 3 oz - Alcon Laboratories, Inc.

Duns Number:008018525

Device Description: CLEAR CARE 3 oz

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More Product Details

Catalog Number

-

Brand Name

CLEAR CARE

Version/Model Number

Clear Care 3oz

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

-

Product Code Details

Product Code

LPN

Product Code Name

Accessories, soft lens products

Device Record Status

Public Device Record Key

3acd6b2c-a116-4128-b6b7-71c18979922c

Public Version Date

March 04, 2020

Public Version Number

1

DI Record Publish Date

February 25, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ALCON LABORATORIES, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 250
2 A medical device with a moderate to high risk that requires special controls. 541
3 A medical device with high risk that requires premarket approval 6098