Duns Number:331080432
Catalog Number
LAZ01-08
Brand Name
Applicator-Fixation for Bougie D=8mm
Version/Model Number
LAZ01-08#03
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
e81d54e8-8bde-4551-b309-fbd9fdc01f70
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 07, 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 |