Catalog Number

-

Brand Name

Enucleation/Evisceration Sizer

Version/Model Number

A1-014

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

FTY

Product Code Name

Tape, Measuring, Rulers And Calipers

Public Device Record Key

75d7a2d1-8d71-4a3f-bab3-c7d070d333b5

Public Version Date

December 03, 2019

Public Version Number

1

DI Record Publish Date

November 25, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-