Vilex Tool - Sizer, CHI 1st MPJ 19x22 #4 - VILEX IN TENNESSEE, INC.

Duns Number:152008371

Device Description: Sizer, CHI 1st MPJ 19x22 #4

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More Product Details

Catalog Number

M1SZ-1922

Brand Name

Vilex Tool

Version/Model Number

M1SZ-1922

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

HWT

Product Code Name

Template

Device Record Status

Public Device Record Key

d1f296f6-fce1-4405-b464-85da25215a39

Public Version Date

May 25, 2020

Public Version Number

3

DI Record Publish Date

October 30, 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