Duns Number:545245755
Device Description: FOOT PEDAL REPLACEMENT PART FOR AVEOPUMP
Catalog Number
-
Brand Name
BEAMER AVEO IRRIGATION PUMP FOOT PEDAL REPLACEMENT PART
Version/Model Number
PUMP-1
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
January 01, 2024
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
-
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
K210618,K210618
Product Code
OCX
Product Code Name
Endoscopic Irrigation/Suction System
Public Device Record Key
c7753a17-300c-4dca-bb51-32fcd5cbd78b
Public Version Date
March 02, 2022
Public Version Number
1
DI Record Publish Date
February 22, 2022
Package DI Number
06946332803732
Quantity per Package
10
Contains DI Package
06946332803725
Package Discontinue Date
January 01, 2024
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 5 |