Catalog Number

RFS-DS35

Brand Name

RFS Instrument

Version/Model Number

RFS-DS35

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 31, 2017

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

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

LXH

Product Code Name

Orthopedic Manual Surgical Instrument

Public Device Record Key

d81d8db6-c16a-4455-8c9d-d2d0c517d6b6

Public Version Date

April 06, 2020

Public Version Number

4

DI Record Publish Date

September 20, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-