Duns Number:051437143
Device Description: Syringes for Collection, Decantation and Re-injection of Autologous Tissue.
Catalog Number
3-TT-SFL60x3
Brand Name
Tissu-Trans Syringe Fill
Version/Model Number
Linear Syringe Fill 60X3
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
K102117
Product Code
MUU
Product Code Name
System, Suction, Lipoplasty
Public Device Record Key
8556bc59-0636-4c0c-8480-4f01ef51eb85
Public Version Date
January 08, 2021
Public Version Number
7
DI Record Publish Date
August 12, 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 |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 567 |
2 | A medical device with a moderate to high risk that requires special controls. | 13 |