RENOVOLIFE LLC - Intramedullary Fixation Rod, 4.5mm - RENOVO LIFE LLC

Duns Number:059066475

Device Description: Intramedullary Fixation Rod, 4.5mm

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More Product Details

Catalog Number

RNL-251-004

Brand Name

RENOVOLIFE LLC

Version/Model Number

RNL251004

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

Yes

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

HSB

Product Code Name

Rod, Fixation, Intramedullary And Accessories

Device Record Status

Public Device Record Key

9494f19e-24cd-4910-a3af-f8bace3c7a3d

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

November 10, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"RENOVO LIFE LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 36
2 A medical device with a moderate to high risk that requires special controls. 3