Duns Number:121622872
Device Description: CER-LP PROCESS DISPOSABLE PACKPN: 69001-01M
Catalog Number
CER-LP-40
Brand Name
Cervos Lipo Pro Double Pack
Version/Model Number
CER-LP-40
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"
Yes
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
K150156,K150156,K150156,K150156
Product Code
MUU
Product Code Name
System, Suction, Lipoplasty
Public Device Record Key
8bdb58db-2f52-4293-bcfc-230104e4e8b5
Public Version Date
September 15, 2022
Public Version Number
2
DI Record Publish Date
March 17, 2022
Package DI Number
10850023741575
Quantity per Package
15
Contains DI Package
00850023741578
Package Discontinue Date
September 14, 2022
Package Status
Not 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 | 31 |
2 | A medical device with a moderate to high risk that requires special controls. | 93 |