Catalog Number

MDS1401S07R

Brand Name

Distal Radius Plate, Standard, 7 Hole, Right

Version/Model Number

MDS1401S07R

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 13, 2020

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

-

Product Code

HRS

Product Code Name

Plate, Fixation, Bone

Public Device Record Key

ba2475e4-f89b-4c74-ab63-ef91bb2567f7

Public Version Date

January 21, 2020

Public Version Number

1

DI Record Publish Date

January 13, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-