Catalog Number

RNL-310-350

Brand Name

Renovo Life, LLC

Version/Model Number

RNL-310-350

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

HTW

Product Code Name

Bit, Drill

Public Device Record Key

3129d05e-d3f8-463e-b7ce-f3ac7e94ac7b

Public Version Date

November 22, 2018

Public Version Number

3

DI Record Publish Date

November 14, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-