Catalog Number

110899

Brand Name

CHS

Version/Model Number

110899

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

K123055,K123055

Product Code

HRS

Product Code Name

PLATE, FIXATION, BONE

Public Device Record Key

d6047749-4db2-40cf-a180-59de6e3d1162

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 29, 2015

Package DI Number

23596010036470

Quantity per Package

6

Contains DI Package

03596010036476

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BX