BENCOX Mirabo Cup System - Bencox Mirabo Cup Multi Hole D56 - Corentec Co., Ltd

Duns Number:688739895

Device Description: Bencox Mirabo Cup Multi Hole D56

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More Product Details

Catalog Number

-

Brand Name

BENCOX Mirabo Cup System

Version/Model Number

H3.A15.0056

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

Yes

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

K182221

Product Code Details

Product Code

LPH

Product Code Name

Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

Device Record Status

Public Device Record Key

a794993c-77a0-4399-bf33-c44fc011e6cf

Public Version Date

July 12, 2019

Public Version Number

1

DI Record Publish Date

July 04, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CORENTEC CO., LTD" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 327
2 A medical device with a moderate to high risk that requires special controls. 8249