Catalog Number

VT-77070

Brand Name

RONDO'

Version/Model Number

Rondo' cannulated screw ø8mm L70mm

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

Yes

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

K113388

Product Code

HTN

Product Code Name

Washer, Bolt Nut

Public Device Record Key

c5203faa-ae7f-45ae-bea5-2b44dc9605b0

Public Version Date

November 02, 2020

Public Version Number

1

DI Record Publish Date

October 25, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-