SMARTSET - SmartSet ENDURANCE MV Medium Viscosity Bone - DEPUY (IRELAND)

Duns Number:989365556

Device Description: SmartSet ENDURANCE MV Medium Viscosity Bone Cement 80g

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More Product Details

Catalog Number

3102080

Brand Name

SMARTSET

Version/Model Number

3102-080

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

K033382,K041656,K042591,P960001,P960001,P960001,P960001,P960001,P960001,K042591,K041656,K033382,P960001,P960001,P960001,K042591,K041656,K033382

Product Code Details

Product Code

JDZ

Product Code Name

MIXER, CEMENT, FOR CLINICAL USE

Device Record Status

Public Device Record Key

af7e2abc-d444-4130-ba55-cd6f476cff5f

Public Version Date

June 19, 2020

Public Version Number

5

DI Record Publish Date

September 24, 2015

Additional Identifiers

Package DI Number

20603295168352

Quantity per Package

10

Contains DI Package

10603295168355

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PACKAGE

"DEPUY (IRELAND)" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3549
2 A medical device with a moderate to high risk that requires special controls. 2188
3 A medical device with high risk that requires premarket approval 418