Duns Number:961394798
Device Description: The VERIFY General Purpose EO Process Indicator Tape adheres to both natural and synthetic The VERIFY General Purpose EO Process Indicator Tape adheres to both natural and synthetic materials commonly used in sterile processing. They are used to identify processed packs from unprocessed packs.
Catalog Number
410100
Brand Name
NA
Version/Model Number
410100
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 08, 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)
Yes
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
K890760,K890760
Product Code
JOJ
Product Code Name
Indicator, physical/chemical sterilization process
Public Device Record Key
745841b2-7450-44ab-99da-28101b2d3ee1
Public Version Date
April 08, 2020
Public Version Number
6
DI Record Publish Date
September 09, 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 |
|---|---|---|
| 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 |