Catalog Number

-

Brand Name

CelioFlex™ 5 N

Version/Model Number

FP-10036

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K193416

Product Code

OWN

Product Code Name

Confocal Optical Imaging

Public Device Record Key

74db693b-97b5-4150-9fbb-d746f3a8aaf9

Public Version Date

July 26, 2021

Public Version Number

2

DI Record Publish Date

May 15, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-