Vilex Plate - Sizer, Wedge Plate 4mm - VILEX LLC

Duns Number:117502293

Device Description: Sizer, Wedge Plate 4mm

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More Product Details

Catalog Number

WSZ04

Brand Name

Vilex Plate

Version/Model Number

WSZ04

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

K041287

Product Code Details

Product Code

HWT

Product Code Name

Template

Device Record Status

Public Device Record Key

87bfd77b-134f-4d5a-8f88-ba0ff7b8ea52

Public Version Date

May 20, 2021

Public Version Number

1

DI Record Publish Date

May 12, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"VILEX LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 81
2 A medical device with a moderate to high risk that requires special controls. 1478