Dynex - Wrench, Combo 13mm - VILEX LLC

Duns Number:117502293

Device Description: Wrench, Combo 13mm

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More Product Details

Catalog Number

915-CW-13

Brand Name

Dynex

Version/Model Number

DF-915-CW-13

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

HXC

Product Code Name

Wrench

Device Record Status

Public Device Record Key

e4fcd8c9-69cc-468c-bd83-30dab6912950

Public Version Date

September 28, 2021

Public Version Number

1

DI Record Publish Date

September 20, 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