Catalog Number

-

Brand Name

BONASSE

Version/Model Number

BC-790+

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K991206

Product Code

LRX

Product Code Name

Case, Contact Lens

Public Device Record Key

975e0d81-f5b1-451d-bbb9-51a8c737805b

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

December 21, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-