Duns Number:315304071
Device Description: FOOTSWITCH 1 PEDAL for Piranha Suction Pump 2208
Catalog Number
2030108
Brand Name
PIRANHA
Version/Model Number
2030108
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
JCX
Product Code Name
APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED
Public Device Record Key
9e58d7ed-8fd3-443b-9876-e06e7e74c96b
Public Version Date
April 30, 2021
Public Version Number
5
DI Record Publish Date
July 21, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 587 |
2 | A medical device with a moderate to high risk that requires special controls. | 1835 |