Catalog Number

-

Brand Name

Wexler Surgical, Inc.

Version/Model Number

VL1124.3

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

GZX

Product Code Name

Instrument, Microsurgical

Public Device Record Key

303e1f7f-d765-4352-9483-2185e2152f6b

Public Version Date

November 25, 2021

Public Version Number

2

DI Record Publish Date

April 18, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-