Acetabular reamer ø48mm - Acetabular reamer for hip arthroplasty - Incipio Devices SA

Duns Number:485098284

Device Description: Acetabular reamer for hip arthroplasty

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

AC-R1-48

Brand Name

Acetabular reamer ø48mm

Version/Model Number

AC-R1-48

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

316d1dce-4489-48cd-8ff1-c55b50368bda

Public Version Date

April 04, 2022

Public Version Number

1

DI Record Publish Date

March 25, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"INCIPIO DEVICES SA" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 374