Carbon offset reamer handle Hudson dual coupling - Offset Reamer handles designed for required - MPS Precimed SA

Duns Number:486741981

Device Description: Offset Reamer handles designed for required minimally invasive surgical approach of the hi Offset Reamer handles designed for required minimally invasive surgical approach of the hip joint. A non clipped and dual connection with reamer cutting tool and 3 couplings with power tool (Big AO, Stryker-Zimmer/Hall and Hudson) are available. It could be disassembled in 5 parts allowing the cleaning of the instrument. This is a reusable device.

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More Product Details

Catalog Number

T17876

Brand Name

Carbon offset reamer handle Hudson dual coupling

Version/Model Number

T17876

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

f4556057-7c49-4b8e-820d-d30b9d524e15

Public Version Date

August 21, 2020

Public Version Number

1

DI Record Publish Date

August 13, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MPS PRECIMED SA" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 299