Duns Number:194877072
Device Description: Chemical indicator strips provide distinct color change when exposed to EO Gas sterilizati Chemical indicator strips provide distinct color change when exposed to EO Gas sterilization cycle
Catalog Number
GIL-250
Brand Name
EO GAS INDICATOR STRIP
Version/Model Number
GIL-250
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
-
Product Code
JOJ
Product Code Name
Indicator, physical/chemical sterilization process
Public Device Record Key
7827842d-50ee-4218-8640-ceaa7099bf7d
Public Version Date
February 19, 2021
Public Version Number
3
DI Record Publish Date
November 15, 2016
Package DI Number
50732224710315
Quantity per Package
10
Contains DI Package
10732224710317
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 26 |