Duns Number:079376107
Device Description: PROSPORE AUTOCLAVE AMPULE 10/BOX
Catalog Number
3471
Brand Name
PROSPORE AUTOCLAVE AMPULE 10/BOX
Version/Model Number
3471
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)
Yes
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
1d65abe9-0512-4648-bc16-07677438caf5
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
October 04, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-