Catalog Number

-

Brand Name

STERILIZABLE HANDLE FOR UNICA/U29

Version/Model Number

Z400307-4

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

FTA

Product Code Name

Light, Surgical, Accessories

Public Device Record Key

cc0443a1-973c-46b7-97a3-871966fe6e5e

Public Version Date

October 26, 2020

Public Version Number

1

DI Record Publish Date

October 16, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-