Duns Number:388000270
Device Description: Safety-Multifly® 21G tube 80mm
Catalog Number
85.1638.205
Brand Name
Safety-Multifly®-Needle
Version/Model Number
85.1638.205
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)
Yes
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
45fe8006-39f5-4901-86ff-97d5d43635cd
Public Version Date
July 23, 2020
Public Version Number
5
DI Record Publish Date
September 16, 2016
Package DI Number
04038917322515
Quantity per Package
400
Contains DI Package
04038917132398
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 6 |