Duns Number:001483130
Device Description: Duo Spore® Biological Indicator Test - Steam or Ethylene Oxide - 12 Test Envelopes No Pro Duo Spore® Biological Indicator Test - Steam or Ethylene Oxide - 12 Test Envelopes No Processing
Catalog Number
26909500
Brand Name
Propper Duo Spore Biological Indicators
Version/Model Number
26909500
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FRC
Product Code Name
Indicator, Biological Sterilization Process
Public Device Record Key
8c179ff0-7026-4870-bc79-abe217767830
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
October 17, 2017
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 | 58 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 49 |