Catalog Number

26-1085

Brand Name

Symmetry Children's Hospital

Version/Model Number

26-1085

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

January 01, 9999

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

-

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

-

Product Code

HBG

Product Code Name

Drills, Burrs, Trephines & Accessories (Manual)

Public Device Record Key

ae80ee56-eb62-492c-9983-12c8e2732d04

Public Version Date

November 22, 2018

Public Version Number

3

DI Record Publish Date

May 31, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-