Catalog Number

6000205-5

Brand Name

APEX

Version/Model Number

APXSC8

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

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

K963682

Product Code

FSY

Product Code Name

Light, Surgical, Ceiling Mounted

Public Device Record Key

73d1c5f0-1405-46bc-957b-e21f3fba0e25

Public Version Date

January 08, 2021

Public Version Number

4

DI Record Publish Date

June 24, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-