Diamond Orthopedic, LLC - Handle with quick-coupling - DIAMOND ORTHOPEDIC, LLC

Duns Number:080596041

Device Description: Handle with quick-coupling

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More Product Details

Catalog Number

DMD-311-430

Brand Name

Diamond Orthopedic, LLC

Version/Model Number

DMD-311-430

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

-

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

HXX

Product Code Name

Screwdriver

Device Record Status

Public Device Record Key

fa3d9086-bb0a-4dcd-a02d-94acb74e26d4

Public Version Date

October 05, 2018

Public Version Number

4

DI Record Publish Date

September 29, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DIAMOND ORTHOPEDIC, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 15
2 A medical device with a moderate to high risk that requires special controls. 708