Catalog Number

VP-91010

Brand Name

RONDO'

Version/Model Number

Screwdriver for ø3-4mm screws

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

K113388

Product Code

HTN

Product Code Name

Washer, Bolt Nut

Public Device Record Key

4a438282-81bc-47f4-be5f-b6db8ce0cb79

Public Version Date

October 05, 2018

Public Version Number

5

DI Record Publish Date

September 26, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-