Duns Number:187129721
Device Description: A sterilization indicator designed to respond with a characteristic chemical or physical c A sterilization indicator designed to respond with a characteristic chemical or physical change to one or more of the physical conditions within the sterilizing chamber. This is a single-use device.
Catalog Number
IND400S
Brand Name
IND400S
Version/Model Number
IND400S
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 26, 2021
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K875193,K875193
Product Code
JOJ
Product Code Name
Indicator, Physical/Chemical Sterilization Process
Public Device Record Key
63c15018-dbac-4ccb-aa3a-7288f2863e12
Public Version Date
November 26, 2021
Public Version Number
3
DI Record Publish Date
November 27, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-