Mediflex Universal Round Bar Table Mounted Retractor Systems - Universal TMR Blade, Balfour, 3 1/2 " x 3" , - FLEXBAR MACHINE CORPORATION

Duns Number:047644935

Device Description: Universal TMR Blade, Balfour, 3 1/2 " x 3" , Swivel

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More Product Details

Catalog Number

-

Brand Name

Mediflex Universal Round Bar Table Mounted Retractor Systems

Version/Model Number

75261

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

FFO

Product Code Name

Retractor, Self-Retaining

Device Record Status

Public Device Record Key

13677eb6-eded-4867-a668-511dcf885afa

Public Version Date

September 27, 2021

Public Version Number

1

DI Record Publish Date

September 17, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"FLEXBAR MACHINE CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 882
2 A medical device with a moderate to high risk that requires special controls. 595