Catalog Number

BPL020

Brand Name

Body Pro-Lok ONE™ Rails-Only System

Version/Model Number

BPL020

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K973842

Product Code

IXQ

Product Code Name

Table, radiographic, stationary top

Public Device Record Key

e214c63a-8f7f-4b55-88f5-dda6f42258df

Public Version Date

March 12, 2020

Public Version Number

7

DI Record Publish Date

August 02, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-