Catalog Number

5438

Brand Name

NA

Version/Model Number

Style 276

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K023481,K023481

Product Code

HQX

Product Code Name

Implant, Orbital, Extra-Ocular

Public Device Record Key

e69e08e1-9966-4420-a1b3-af73bbcaa425

Public Version Date

December 22, 2021

Public Version Number

4

DI Record Publish Date

December 22, 2017

Package DI Number

30818255011372

Quantity per Package

5

Contains DI Package

10818255011378

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton