Duns Number:256900895
Device Description: Description of the test packs kit (TSO3 product code 44020):• Syringe with plunger• Diffus Description of the test packs kit (TSO3 product code 44020):• Syringe with plunger• Diffusion restrictor
Catalog Number
44020
Brand Name
STERIZONE® VP4 Test Pack Kit
Version/Model Number
44020
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K141580
Product Code
FRC
Product Code Name
Indicator, Biological Sterilization Process
Public Device Record Key
c3e898aa-bf1c-42c5-9f1c-73a8e15bdc1e
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 14, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |