Duns Number:260069352
Device Description: This kit is a convenience kit. The devices contained in the infiltration kit are used to c This kit is a convenience kit. The devices contained in the infiltration kit are used to collect fat tissue. The procedure usually involves infiltration of tumescent solution before harvesting fat tissue by liposuction.
Catalog Number
PACK001-BI
Brand Name
Infiltration kit
Version/Model Number
1
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
FTN
Product Code Name
Plastic Surgery And Accessories Kit
Public Device Record Key
abbcd198-4a9f-4ce3-9dc5-ba86976aa538
Public Version Date
August 23, 2021
Public Version Number
1
DI Record Publish Date
August 15, 2021
Package DI Number
03760173233700
Quantity per Package
10
Contains DI Package
03760173233694
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 92 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 49 |