Duns Number:078375583
Device Description: Integrity 215 Vacuum/Gravity Steam Sterilizer, 21.5"W x 21.5"H x 38"D, Vertical Power Slid Integrity 215 Vacuum/Gravity Steam Sterilizer, 21.5"W x 21.5"H x 38"D, Vertical Power Sliding Door w/ Foot Pedal Control, Water Ejector Vacuum System, House Steam
Catalog Number
INTEGRITY 215
Brand Name
Integrity Sterilizers
Version/Model Number
INTEGRITY 215
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
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K120149
Product Code
FLE
Product Code Name
Sterilizer, steam
Public Device Record Key
28e47acd-dbf8-49b6-acd0-ff60c276fb46
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 19, 2016
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 | 747 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 265 |