Corin BiPolar-i - Acetabular Trial Ø60 - CORIN LTD

Duns Number:295437313

Device Description: Acetabular Trial Ø60

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More Product Details

Catalog Number

2110060

Brand Name

Corin BiPolar-i

Version/Model Number

2110060

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

K183114

Product Code Details

Product Code

KWY

Product Code Name

Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented

Device Record Status

Public Device Record Key

450ea0f9-c97b-4c3f-a3bd-3d28f168e97a

Public Version Date

August 02, 2019

Public Version Number

1

DI Record Publish Date

July 25, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CORIN LTD" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 3697
3 A medical device with high risk that requires premarket approval 21