Catalog Number

SD900.105

Brand Name

ProPlan CMF

Version/Model Number

SD900.105

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 01, 2017

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

K103136

Product Code

JEY

Product Code Name

Plate, Bone

Public Device Record Key

de52cfdc-1976-47a3-837c-ffe8f4926d73

Public Version Date

December 04, 2020

Public Version Number

4

DI Record Publish Date

September 13, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-