Distal Radius Plate - Distal Radius Plate, Standard, 4 Holes, Left - MIAMI DEVICE SOLUTIONS LLC

Duns Number:078703080

Device Description: Distal Radius Plate, Standard, 4 Holes, Left

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More Product Details

Catalog Number

MDS1401S04L

Brand Name

Distal Radius Plate

Version/Model Number

MDS1401S04L

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

HRS

Product Code Name

Plate, Fixation, Bone

Device Record Status

Public Device Record Key

1273fadb-8221-4fc9-a2b9-d5cee20e12f5

Public Version Date

January 17, 2019

Public Version Number

1

DI Record Publish Date

December 17, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MIAMI DEVICE SOLUTIONS LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 464