Offset Cup Impactor - 3/8-24 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

SSI006232

Brand Name

Offset Cup Impactor - 3/8-24 interface

Version/Model Number

SSI006232

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

a2a3a958-f772-4a94-8080-4f7e45ea739c

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