Duns Number:260069352
Device Description: 2,75 mm x 15 cm - 18-hole Rough
Catalog Number
CP121512R
Brand Name
DISPOSABLE FAT HARVESTING CANNULA
Version/Model Number
18-hole Rough
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 06, 2022
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
9ea80e5d-faa4-47db-a04c-c5336a6ea757
Public Version Date
April 14, 2022
Public Version Number
1
DI Record Publish Date
April 06, 2022
Package DI Number
03701068806104
Quantity per Package
10
Contains DI Package
03701068806098
Package Discontinue Date
April 06, 2022
Package Status
Not 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 | 92 |
2 | A medical device with a moderate to high risk that requires special controls. | 49 |