Catalog Number

VT-79105

Brand Name

RONDO'

Version/Model Number

Screw ø8mm L105-40mm

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

b6a4b0ac-4120-4a04-aa7b-7c34187f6458

Public Version Date

July 06, 2018

Public Version Number

2

DI Record Publish Date

March 13, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-