Catalog Number

72204506

Brand Name

DYONICS

Version/Model Number

72204506

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

K863734,K863734,K863734

Product Code

HTY

Product Code Name

PIN, FIXATION, SMOOTH

Public Device Record Key

4b014fee-c563-4159-bb0a-a0922d1a9115

Public Version Date

January 22, 2021

Public Version Number

5

DI Record Publish Date

June 07, 2017

Package DI Number

20885554035982

Quantity per Package

4

Contains DI Package

00885554035988

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PK