NA - CURETTE 8mm x 21in - DEPUY ORTHOPAEDICS, INC.

Duns Number:080506581

Device Description: CURETTE 8mm x 21in

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More Product Details

Catalog Number

602036000

Brand Name

NA

Version/Model Number

6020-36-000

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

-

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

HTF

Product Code Name

CURETTE

Device Record Status

Public Device Record Key

794fca63-107d-414e-8782-e565ec472b57

Public Version Date

May 07, 2019

Public Version Number

2

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