Catalog Number

-

Brand Name

Kii Fios First Entry

Version/Model Number

CFF75

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

GCJ

Product Code Name

Laparoscope, General & Plastic Surgery

Public Device Record Key

88cba114-9016-407b-8135-2b92fe8f3bda

Public Version Date

January 09, 2020

Public Version Number

3

DI Record Publish Date

December 25, 2017

Package DI Number

10607915136656

Quantity per Package

6

Contains DI Package

00607915136659

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-