Offset Cup Impactor - M10x1.5 interface - Offset Cup Impactor for hip arthroplasty - Incipio Devices SA

Duns Number:485098284

Device Description: Offset Cup Impactor for hip arthroplasty

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More Product Details

Catalog Number

50340704

Brand Name

Offset Cup Impactor - M10x1.5 interface

Version/Model Number

50340704

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

HWA

Product Code Name

Impactor

Device Record Status

Public Device Record Key

f914f785-2a70-4078-b41f-b83f245db927

Public Version Date

September 14, 2020

Public Version Number

1

DI Record Publish Date

September 04, 2020

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