Duns Number:260069352
Device Description: 2,5mm x 25 cm - 10-hole
Catalog Number
CI25250
Brand Name
DISPOSABLE TUMESCENT INFILTRATION CANNULA
Version/Model Number
10-hole
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
K132353,K132353
Product Code
MUU
Product Code Name
System, Suction, Lipoplasty
Public Device Record Key
d393dd72-b49e-48b4-a9b4-6cd2c76c810c
Public Version Date
May 09, 2022
Public Version Number
1
DI Record Publish Date
April 29, 2022
Package DI Number
03701068800812
Quantity per Package
10
Contains DI Package
03701068800829
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 |