Catalog Number

VT-78120

Brand Name

RONDO'

Version/Model Number

Screw ø8mm L120-20mm

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

00532957-9154-423a-84c9-85bba70f5cf3

Public Version Date

July 06, 2018

Public Version Number

2

DI Record Publish Date

March 11, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-