Duns Number:102530326
Device Description: Mesa Labs dual species spore strip controls - 10e5/10e6 population. 1000 count package
Catalog Number
5-1000C
Brand Name
Dual Spore Strips - Control
Version/Model Number
10e5/10e6
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
09a833d6-bd22-4291-978f-270e12d0bb69
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
October 20, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 29 |