Catalog Number

-

Brand Name

EQUATE

Version/Model Number

SC-110

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K991206,K991206

Product Code

LRX

Product Code Name

Case, Contact Lens

Public Device Record Key

3d6281b9-7880-4515-bd99-c20f64f57ad6

Public Version Date

November 02, 2018

Public Version Number

1

DI Record Publish Date

October 02, 2018

Package DI Number

10681131248911

Quantity per Package

1

Contains DI Package

00681131248914

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-