Catalog Number

CP20025

Brand Name

PediatrOS™ FlexTack™

Version/Model Number

25

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

K151762

Product Code

JDR

Product Code Name

Staple, Fixation, Bone

Public Device Record Key

c131eab5-e2c7-4624-95f2-65b4a721b010

Public Version Date

November 23, 2021

Public Version Number

5

DI Record Publish Date

February 29, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-