Uni Tibial Insert - Uni Tibial Insert 4x8 - SIGNAL MEDICAL CORPORATION

Duns Number:169289308

Device Description: Uni Tibial Insert 4x8

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More Product Details

Catalog Number

WZ-1-1044

Brand Name

Uni Tibial Insert

Version/Model Number

4x8

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

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

K012800

Product Code Details

Product Code

HRY

Product Code Name

Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer

Device Record Status

Public Device Record Key

6d61e4d0-2b41-4295-a0fd-0875638e470e

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

March 25, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SIGNAL MEDICAL CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 14
2 A medical device with a moderate to high risk that requires special controls. 233