Duns Number:622223196
Catalog Number
-
Brand Name
Getinge Assured MI Steam Migrating Integrator Strip
Version/Model Number
61301606825
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
K200252,K200252,K200252
Product Code
JOJ
Product Code Name
Indicator, Physical/Chemical Sterilization Process
Public Device Record Key
e9697639-c328-4651-a687-64a83371cbe7
Public Version Date
February 19, 2021
Public Version Number
2
DI Record Publish Date
July 17, 2020
Package DI Number
30814434021231
Quantity per Package
250
Contains DI Package
00814434021230
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Bag
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 61 |