Duns Number:622223196
Catalog Number
61301606668
Brand Name
Getinge Assured Green Tape 3/4"
Version/Model Number
61301606668
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"
Yes
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
5171b382-458b-4b17-88d4-6318c5595f12
Public Version Date
June 17, 2022
Public Version Number
1
DI Record Publish Date
June 09, 2022
Package DI Number
10814434021633
Quantity per Package
48
Contains DI Package
00814434021636
Package Discontinue Date
-
Package Status
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 |