Catalog Number

-

Brand Name

ENFOCUS 2300 INTEGRATED OCT

Version/Model Number

90-C2350-V4

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

K162783

Product Code

OBO

Product Code Name

Tomography, optical coherence

Public Device Record Key

a0172914-5a89-4d12-bd2b-4178d89ba0b6

Public Version Date

November 27, 2020

Public Version Number

1

DI Record Publish Date

November 19, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-