ENGAGE - POROUS COATED FEMORAL COMP, SIZE - Smith & Nephew, Inc.

Duns Number:109903521

Device Description: POROUS COATED FEMORAL COMP, SIZE 4-LEFT MEDIAL

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More Product Details

Catalog Number

1-10003-410

Brand Name

ENGAGE

Version/Model Number

1-10003-410

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

K190439

Product Code Details

Product Code

HSX

Product Code Name

PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Device Record Status

Public Device Record Key

91df4f56-7d66-4727-9f8c-a2662b145118

Public Version Date

May 26, 2022

Public Version Number

1

DI Record Publish Date

May 18, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SMITH & NEPHEW, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 10651
2 A medical device with a moderate to high risk that requires special controls. 35590
3 A medical device with high risk that requires premarket approval 351