0.094" x 6" K-Wire Standard - Trilliant Surgical, LLC

Duns Number:828829072

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More Product Details

Catalog Number

-

Brand Name

0.094" x 6" K-Wire Standard

Version/Model Number

330-24-004

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

Yes

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

K181898

Product Code Details

Product Code

HTY

Product Code Name

Pin, Fixation, Smooth

Device Record Status

Public Device Record Key

7757f5b4-e001-4913-a4d3-ac022f5d22bc

Public Version Date

April 06, 2022

Public Version Number

2

DI Record Publish Date

October 01, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"TRILLIANT SURGICAL, LLC" 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. 933