Catalog Number

-

Brand Name

MIRA IMEX Scleral Buckling Component

Version/Model Number

5025

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

K950806,K950806

Product Code

HQX

Product Code Name

Implant, Orbital, Extra-Ocular

Public Device Record Key

f0bb379b-e46a-4375-903a-cffbb0b26eda

Public Version Date

December 22, 2021

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

20850510007259

Quantity per Package

5

Contains DI Package

10850510007252

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box of five