Duns Number:514619238
Device Description: Intraosseous start kit by PerSys Medical
Catalog Number
-
Brand Name
GOIO
Version/Model Number
GOIO
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
-
Product Code
FPA
Product Code Name
Set, Administration, Intravascular
Public Device Record Key
94a5a7db-f176-4199-a627-97b02e046162
Public Version Date
February 21, 2022
Public Version Number
4
DI Record Publish Date
April 05, 2017
Package DI Number
27290008325015
Quantity per Package
12
Contains DI Package
17290008325018
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 3 |
2 | A medical device with a moderate to high risk that requires special controls. | 4 |