K-Wire Depth Gauge - K-Wire Depth Gauge, 2.7T - MIAMI DEVICE SOLUTIONS LLC

Duns Number:078703080

Device Description: K-Wire Depth Gauge, 2.7T

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More Product Details

Catalog Number

MDS100702

Brand Name

K-Wire Depth Gauge

Version/Model Number

MDS100702

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

211c2580-f6b9-4f15-a535-aa22daae5b4e

Public Version Date

December 07, 2018

Public Version Number

3

DI Record Publish Date

June 26, 2017

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