Catalog Number

-

Brand Name

GBR System

Version/Model Number

SDP-T44-044

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

K170697

Product Code

JEY

Product Code Name

Plate, Bone

Public Device Record Key

f36f77c7-3153-486b-b1c8-b7c4322b915a

Public Version Date

February 05, 2021

Public Version Number

3

DI Record Publish Date

August 31, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-