Catalog Number

-

Brand Name

BIO2 TECHNOLOGIES

Version/Model Number

100-0129

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K151876

Product Code

HTY

Product Code Name

Pin, Fixation, Smooth

Public Device Record Key

eae03e17-ddf9-4fba-a0b0-ed5ddf68770c

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

May 12, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-