Dyna Locking Trochanteric Nail™ - U&I CORPORATION

Duns Number:688811082

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More Product Details

Catalog Number

-

Brand Name

Dyna Locking Trochanteric Nail™

Version/Model Number

32136

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

K093707

Product Code Details

Product Code

HSB

Product Code Name

ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Device Record Status

Public Device Record Key

161628fc-278f-464c-b37a-0bd690e192b1

Public Version Date

October 25, 2021

Public Version Number

1

DI Record Publish Date

October 16, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"U&I CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2058
2 A medical device with a moderate to high risk that requires special controls. 10186
U Unclassified 24