Catalog Number

-

Brand Name

Xpand

Version/Model Number

346722

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

-

Product Code

HOC

Product Code Name

Clip, Iris Retractor

Public Device Record Key

ca96b49e-df34-414a-b457-0fb0d9f7fbb5

Public Version Date

November 01, 2019

Public Version Number

1

DI Record Publish Date

October 24, 2019

Package DI Number

00813059013934

Quantity per Package

4

Contains DI Package

00813059013927

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box