Catalog Number

-

Brand Name

Wexler Surgical, Inc.

Version/Model Number

CL0742.1

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 13, 2020

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

GDF

Product Code Name

Guide, Needle, Surgical

Public Device Record Key

ddc021ac-5dd4-42a9-823a-c1e43315df4f

Public Version Date

August 21, 2020

Public Version Number

3

DI Record Publish Date

February 26, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-