Vilex Tool - Depth gauge, 230mm white slot - VILEX IN TENNESSEE, INC.

Duns Number:152008371

Device Description: Depth gauge, 230mm white slot

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More Product Details

Catalog Number

Z235-230

Brand Name

Vilex Tool

Version/Model Number

Z235-230

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

-

Product Code Details

Product Code

HTJ

Product Code Name

Gauge, Depth

Device Record Status

Public Device Record Key

8c3e80a2-c548-4e17-a905-e39a17be9f12

Public Version Date

May 25, 2020

Public Version Number

4

DI Record Publish Date

August 03, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"VILEX IN TENNESSEE, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 345
2 A medical device with a moderate to high risk that requires special controls. 540