Duns Number:622223196
Catalog Number
6001154902
Brand Name
Getinge Assured Green Tape 18mm (Steam)
Version/Model Number
6001154902
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 25, 2018
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
K122555,K122555
Product Code
JOJ
Product Code Name
Indicator, Physical/Chemical Sterilization Process
Public Device Record Key
d3281b47-fa82-4b17-9736-2d0c418e5294
Public Version Date
September 26, 2018
Public Version Number
4
DI Record Publish Date
September 23, 2016
Package DI Number
10814434020438
Quantity per Package
48
Contains DI Package
00814434020431
Package Discontinue Date
September 25, 2018
Package Status
Not in Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 61 |