Catalog Number

KF100

Brand Name

Kera-Flow

Version/Model Number

KF100

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

KYG

Product Code Name

Device, Irrigation, Ocular Surgery

Public Device Record Key

2c71013c-7b01-4207-9f55-7da5e667578d

Public Version Date

September 18, 2019

Public Version Number

1

DI Record Publish Date

September 10, 2019

Package DI Number

B360KF1000

Quantity per Package

1

Contains DI Package

B360KF100

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Pouch