b-ONE™ Primary Acetabular System - ACETABULAR REAMER, 53MM - B-ONE ORTHO, CORP.

Duns Number:081315444

Device Description: ACETABULAR REAMER, 53MM

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More Product Details

Catalog Number

8819046053

Brand Name

b-ONE™ Primary Acetabular System

Version/Model Number

8819046053

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)

Yes

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

71421687-dabf-42c8-91ea-d4ada31fc2e1

Public Version Date

March 25, 2019

Public Version Number

1

DI Record Publish Date

March 15, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"B-ONE ORTHO, CORP." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 273
2 A medical device with a moderate to high risk that requires special controls. 707