Acetabular reamer ø37mm - Acetabular reamer ø37mm - Incipio Devices SA

Duns Number:485098284

Device Description: Acetabular reamer ø37mm

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More Product Details

Catalog Number

50142037

Brand Name

Acetabular reamer ø37mm

Version/Model Number

50142037

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

7c38af4a-c8b4-4020-b20e-b4448b6cb731

Public Version Date

December 16, 2019

Public Version Number

1

DI Record Publish Date

December 06, 2019

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