Penenberg's acetabular reamer Ø63 - Acetabular reamer for hip arthroplasty - MPS Precimed SA

Duns Number:486741981

Device Description: Acetabular reamer for hip arthroplasty

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More Product Details

Catalog Number

T10942

Brand Name

Penenberg's acetabular reamer Ø63

Version/Model Number

T10942

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

HTO

Product Code Name

Reamer

Device Record Status

Public Device Record Key

c80ec274-1582-482a-ad40-88db8fa3f507

Public Version Date

August 18, 2020

Public Version Number

1

DI Record Publish Date

August 10, 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