Catalog Number

ZBG250T-25

Brand Name

Vilex Tool

Version/Model Number

ZBG250T-25

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K014154

Product Code

HTJ

Product Code Name

Gauge, Depth

Public Device Record Key

12bbbd66-2ddb-46ab-a77a-7814bc39d35f

Public Version Date

May 27, 2020

Public Version Number

6

DI Record Publish Date

April 05, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-