V-Cide - Formaldehyde Device Sterilant - CERTOL INTERNATIONAL, LLC

Duns Number:095153714

Device Description: Formaldehyde Device Sterilant

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More Product Details

Catalog Number

VC338-1

Brand Name

V-Cide

Version/Model Number

VC338

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K970726,K970726

Product Code Details

Product Code

MED

Product Code Name

Sterilant, Medical Devices

Device Record Status

Public Device Record Key

f4e1b0be-60d3-4e51-a229-447de4c7f246

Public Version Date

November 01, 2022

Public Version Number

5

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

H816VC3381

Quantity per Package

16

Contains DI Package

H816VC3380

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case Box

"CERTOL INTERNATIONAL, LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 2