Duns Number:961394798
Device Description: The VERIFY VH202 Indicator Tape is intended to secure items wrapped in synthetic wrap mate The VERIFY VH202 Indicator Tape is intended to secure items wrapped in synthetic wrap materials until used and to distinguish between processed and unprocessed units through a color change. It can be changed in all V-PRO Low Temperature Sterilization Systems and Sterrad 100S, NX and 100NX Sterilizers.
Catalog Number
PCC070
Brand Name
VERIFY
Version/Model Number
PCC070
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 07, 2020
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
-
Product Code
JOJ
Product Code Name
Indicator, physical/chemical sterilization process
Public Device Record Key
f977139f-7942-4f39-aa35-c04137888fc3
Public Version Date
February 07, 2020
Public Version Number
6
DI Record Publish Date
December 07, 2016
Package DI Number
50724995002539
Quantity per Package
6
Contains DI Package
00724995002534
Package Discontinue Date
February 07, 2020
Package Status
Not in Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1528 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1557 |