Duns Number:938289980
Device Description: An assembly of devices designed to evacuate fluid, tissue, gas, or other foreign materials
Catalog Number
201164NS
Brand Name
ADULT DEBRIDEMENT SUCKER HEX HANDLE
Version/Model Number
201164NS
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DTS
Product Code Name
Sucker, Cardiotomy Return, Cardiopulmonary Bypass
Public Device Record Key
839f4ee6-4e4f-451a-894e-b783f969d91a
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
October 13, 2015
Package DI Number
B066201164NS3
Quantity per Package
50
Contains DI Package
B066201164NS1
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
INNER BAG
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 50 |