Catalog Number

72204511

Brand Name

DYONICS

Version/Model Number

72204511

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K863734,K863734

Product Code

HTY

Product Code Name

PIN, FIXATION, SMOOTH

Public Device Record Key

b2a856bb-3afe-4a6d-9db0-5b047217f1d2

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 10, 2016

Package DI Number

20885554035302

Quantity per Package

6

Contains DI Package

00885554035308

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BX