Duns Number:095153714
Device Description: Formaldehyde Device Sterilant
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
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
MED
Product Code Name
Sterilant, Medical Devices
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
Package DI Number
H816VC3381
Quantity per Package
16
Contains DI Package
H816VC3380
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case Box
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 2 |