Catalog Number

-

Brand Name

HEINE MPACK

Version/Model Number

X-007.99.671

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 23, 2018

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

-

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

K142486

Product Code

HLJ

Product Code Name

Ophthalmoscope, Battery-Powered

Public Device Record Key

1bae9989-70fe-4a6b-8dd0-c0192cbadabf

Public Version Date

February 19, 2021

Public Version Number

7

DI Record Publish Date

August 08, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-