Drill Guide for Compression Screw Holes, 3.5T - Drill Guide for Compression Screw Holes, 3.5T - MIAMI DEVICE SOLUTIONS LLC

Duns Number:078703080

Device Description: Drill Guide for Compression Screw Holes, 3.5T

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More Product Details

Catalog Number

MDS110824

Brand Name

Drill Guide for Compression Screw Holes, 3.5T

Version/Model Number

MDS110824

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

-

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

7f72ac4b-9a5b-445f-974d-fedb9341505d

Public Version Date

April 06, 2020

Public Version Number

3

DI Record Publish Date

May 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