Duns Number:331080432
Catalog Number
LAF1000-3
Brand Name
Transfer Tube,D=3mm,L=1000mm,Colour:blue,QuickFix (SagiNova)
Version/Model Number
LAF1000-3#05
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
-
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
K142986
Product Code
JAQ
Product Code Name
System, Applicator, Radionuclide, Remote-Controlled
Public Device Record Key
6fac7a1c-40dd-47f5-8d54-5b5ab83de3e4
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 05, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 221 |