n/a - Acetabular Reamer 52mm - Ortho Development Corporation

Duns Number:876542390

Device Description: Acetabular Reamer 52mm

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More Product Details

Catalog Number

-

Brand Name

n/a

Version/Model Number

228-1052

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

HTO

Product Code Name

REAMER

Device Record Status

Public Device Record Key

5a4bad00-f121-4a9b-b6cf-25e20ea075f6

Public Version Date

August 27, 2020

Public Version Number

1

DI Record Publish Date

August 19, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ORTHO DEVELOPMENT CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3694
2 A medical device with a moderate to high risk that requires special controls. 3650