Duns Number:622223196
Catalog Number
61301606669
Brand Name
Getinge Assured Green Tape 1"
Version/Model Number
61301606669
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
cdfd5cef-8c20-4765-a6a5-ec9790b3eb78
Public Version Date
June 17, 2022
Public Version Number
1
DI Record Publish Date
June 09, 2022
Package DI Number
10814434021640
Quantity per Package
36
Contains DI Package
00814434021643
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 |