Modulus Hip System - Reamer Dia.26mm - LIMACORPORATE SPA

Duns Number:432066322

Device Description: Reamer Dia.26mm

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More Product Details

Catalog Number

9043.10.260

Brand Name

Modulus Hip System

Version/Model Number

Reamer

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

K112158

Product Code Details

Product Code

JDI

Product Code Name

Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

Device Record Status

Public Device Record Key

59656b92-74a8-456f-b6b3-a5a68465410c

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

April 15, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"LIMACORPORATE SPA" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 595
2 A medical device with a moderate to high risk that requires special controls. 3634