Duns Number:102530326
Device Description: ProChem SSW Steam Sterilization Integrator for use in steam sterilizers only. Contains 25 ProChem SSW Steam Sterilization Integrator for use in steam sterilizers only. Contains 250 units (1 bag of 250 each).
Catalog Number
CI-SSW
Brand Name
ProChem SSW
Version/Model Number
Class 5 Integrator
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
JOJ
Product Code Name
Indicator, Physical/Chemical Sterilization Process
Public Device Record Key
2672bc74-07a3-4f26-984a-f3a8ea611955
Public Version Date
May 03, 2018
Public Version Number
1
DI Record Publish Date
April 02, 2018
Package DI Number
M985CISSW250
Quantity per Package
250
Contains DI Package
M985CISSW1
Package Discontinue Date
-
Package Status
In Commercial Distribution
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 |