Catalog Number

-

Brand Name

Wexler Surgical, Inc.

Version/Model Number

DL9044.2

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

GDI

Product Code Name

Dissector, Surgical, General & Plastic Surgery

Public Device Record Key

b35147df-e286-4c1e-b7d7-e0c4adfac7fe

Public Version Date

November 23, 2021

Public Version Number

3

DI Record Publish Date

November 29, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-