OrthoMedFlex - Bridgeback Acetabular Reamer, Size 63mm - ORTHOMEDFLEX LLC

Duns Number:034442726

Device Description: Bridgeback Acetabular Reamer, Size 63mm

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More Product Details

Catalog Number

112-152-263

Brand Name

OrthoMedFlex

Version/Model Number

112152263

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

6d77b507-5eb0-4b52-a65d-3c36da460de2

Public Version Date

April 27, 2020

Public Version Number

1

DI Record Publish Date

April 17, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ORTHOMEDFLEX LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 371
2 A medical device with a moderate to high risk that requires special controls. 435