Duns Number:320405061
Catalog Number
-
Brand Name
TLA Luer-Lock adapter
Version/Model Number
00004027
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
K053451,K053451,K053451
Product Code
MUU
Product Code Name
System, Suction, Lipoplasty
Public Device Record Key
1156a97b-0990-4197-9d3f-441dca5b04a4
Public Version Date
January 29, 2020
Public Version Number
1
DI Record Publish Date
January 21, 2020
Package DI Number
04260632792667
Quantity per Package
20
Contains DI Package
04260632792599
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 | 398 |
2 | A medical device with a moderate to high risk that requires special controls. | 324 |