Renovo Life - Fib Nail T-Handle Reamer, 2.5 - RENOVO LIFE LLC

Duns Number:059066475

Device Description: Fib Nail T-Handle Reamer, 2.5

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More Product Details

Catalog Number

RNL-A20008-25

Brand Name

Renovo Life

Version/Model Number

RNLA2000825

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

LYS

Product Code Name

Bone Mill

Device Record Status

Public Device Record Key

2cffd3ed-9cca-4c8f-b550-eca74545dd9a

Public Version Date

July 23, 2020

Public Version Number

2

DI Record Publish Date

October 28, 2019

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