NA - PREP KIT W/O RESTRICTORS - DEPUY ORTHOPAEDICS, INC.

Duns Number:080506581

Device Description: PREP KIT W/O RESTRICTORS

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More Product Details

Catalog Number

546102000

Brand Name

NA

Version/Model Number

5461-02-000

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)

-

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

KIH

Product Code Name

DISPENSER, CEMENT

Device Record Status

Public Device Record Key

91420d78-12d1-4657-97a6-8c9aa60cc892

Public Version Date

October 25, 2018

Public Version Number

1

DI Record Publish Date

September 24, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DEPUY ORTHOPAEDICS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 5254
2 A medical device with a moderate to high risk that requires special controls. 4003
3 A medical device with high risk that requires premarket approval 908