Duns Number:928308407
Device Description: Surgical Aspirator: 1/3 hp. 0-8.0 scfm / 0-29.8 in. hg. @ sea level, 230 VAC
Catalog Number
IM-K2550-2
Brand Name
Phantom
Version/Model Number
2550-2
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K895761
Product Code
JCX
Product Code Name
Apparatus, Suction, Ward Use, Portable, Ac-Powered
Public Device Record Key
ed2e50ba-35db-4e8b-aa14-ac75af0fe7e5
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 19, 2016
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 | 22 |
2 | A medical device with a moderate to high risk that requires special controls. | 13 |