Initia Total Hip System - STARTING REAMER 5182 - KYOCERA CORPORATION

Duns Number:690557624

Device Description: STARTING REAMER 5182

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More Product Details

Catalog Number

BTJ44949

Brand Name

Initia Total Hip System

Version/Model Number

BTJ44949

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

LXH

Product Code Name

Orthopedic Manual Surgical Instrument

Device Record Status

Public Device Record Key

c99e3da4-61e1-40ec-8f73-9a1e68618db6

Public Version Date

May 21, 2020

Public Version Number

3

DI Record Publish Date

March 29, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"KYOCERA CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 42
2 A medical device with a moderate to high risk that requires special controls. 519