Duns Number:006072078
Device Description: 12 PACK - 2000CC SUCTION CANISTER, RED HYDROPHOBIC LID. FOR USE WITH THE SONOPET ULTRASONI 12 PACK - 2000CC SUCTION CANISTER, RED HYDROPHOBIC LID. FOR USE WITH THE SONOPET ULTRASONIC SURGICAL SYSTEM
Catalog Number
5450-851-012
Brand Name
Bemis
Version/Model Number
5450-851-012
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KDQ
Product Code Name
Bottle, Collection, Vacuum
Public Device Record Key
d412ce12-9c6c-4020-8d4b-38fb17977681
Public Version Date
January 08, 2021
Public Version Number
6
DI Record Publish Date
September 24, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-