Catalog Number

-

Brand Name

Myo/Wire II

Version/Model Number

040-439

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K932513,K932513

Product Code

GAO

Product Code Name

Suture, Nonabsorbable

Public Device Record Key

61dd04d6-a8db-44c4-8dc4-d4c2ef9513bd

Public Version Date

February 05, 2021

Public Version Number

5

DI Record Publish Date

November 20, 2017

Package DI Number

20841291105449

Quantity per Package

12

Contains DI Package

10841291105442

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-